ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
WCM WASTE & COMPLIANCE MANAGEMENT,
510(k) NO: K090156(TRADITIONAL)
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
BINAX, INC.
510(k) NO: K083744(TRADITIONAL)
PRIMAEVA MEDICAL RENESIS SYSTEM
PRIMAEVA MEDICAL, INC.
510(k) NO: K082391(TRADITIONAL)
VERIFY SCBI 275F 3-10
STERIS CORPORATION
510(k) NO: K083665(ABBREVIATED)
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
LUMINEX MOLECULAR DIAGNOSTICS, INC
510(k) NO: K083846(TRADITIONAL)
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
FIAB SPA
510(k) NO: K083428(TRADITIONAL)
VALVED TEARWAY INTRODUCER
MEDCOMP
510(k) NO: K090394(TRADITIONAL)
SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS
COVIDIEN LP, FORMERLY REGISTERED A
510(k) NO: K091869(SPECIAL)
QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
CARDIAC LEAD TECHNOLOGIES, INC.
510(k) NO: K090496(TRADITIONAL)
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
OMRON HEALTHCARE, INC.
510(k) NO: K091676(TRADITIONAL)
EK/P. AERUGINOSA PNA FISH
ADVANDX, INC.
510(k) NO: K092393(TRADITIONAL)
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
HOWMEDICA OSTEONICS CORP.
510(k) NO: K092419(SPECIAL)
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
MEDICAL DEVICE RESOURCE CORP.
510(k) NO: K092284(SPECIAL)
WIENER LAB. URINE STRIP 10 AND 11
WIENER LABORATORIOS S.A.I.C.
510(k) NO: K083724(TRADITIONAL)
GSO PCT SPINAL SYSTEM
GOLD STANDARD ORTHOPAEDICS, LLC
510(k) NO: K091359(TRADITIONAL)
IMRX
IMRIS, INC.
510(k) NO: K091166(TRADITIONAL)
MERETE COMPRESSION SCREWS
MERETE MEDICAL GMBH
510(k) NO: K091798(TRADITIONAL)
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
MEDTRONIC NEUROSURGERY
510(k) NO: K091312(TRADITIONAL)
NEUTRASAL
BARTOR PHARMACAL CO., INC.
510(k) NO: K091718(TRADITIONAL)
MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC.
510(k) NO: K091974(SPECIAL)
CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
CHISON MEDICAL IMAGING CO., LTD.
510(k) NO: K091877(TRADITIONAL)
OPTICAL COHERENCE TOMOGRAPHY ED OCT-2000
TOPCON CORP.
510(k) NO: K092470(SPECIAL)
BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000
BRIDGEPOINT MEDICAL
510(k) NO: K091841(SPECIAL)
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
INNOVA VISION INC.
510(k) NO: K083288(TRADITIONAL)
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
COOK UROLOGICAL, INC.
510(k) NO: K082939(TRADITIONAL)
STAXX XD SYSTEM
SPINE WAVE, INC.
510(k) NO: K090315(TRADITIONAL)
KAPPA LIGHT CHAINS
SENTINEL CH. SPA
510(k) NO: K083602(TRADITIONAL)
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
THERATEST LABORATORIES, INC.
510(k) NO: K090760(TRADITIONAL)
COMFORT TWIN NASAL MASK
RESPIRONICS INC., SLEEP & HOME RES
510(k) NO: K091066(TRADITIONAL)
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
PERKINELMER, INC.
510(k) NO: K090846(TRADITIONAL)
INSUFLOW DEWHEART
LEXION MEDICAL, LLC.
510(k) NO: K091366(TRADITIONAL)
VENUS DIAMOND FLOW
HERAEUS KULZER, LLC
510(k) NO: K091635(ABBREVIATED)
SPK SEALANT
3M COMPANY
510(k) NO: K091632(TRADITIONAL)
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
KIMBERLY-CLARK CORP.
510(k) NO: K091685(TRADITIONAL)
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
CYNOSURE, INC.
510(k) NO: K091537(TRADITIONAL)
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
ORTHO-CLINICAL DIAGNOSTICS, INC.
510(k) NO: K091861(SPECIAL)
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
OLYMPUS MEDICAL SYSTEMS CORPORATIO
510(k) NO: K091495(TRADITIONAL)
JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
PATHWAY MEDICAL TECHNOLOGIES, INC.
510(k) NO: K092332(SPECIAL)
SPIROPRO
VIASYS HEALTHCARE GMBH
510(k) NO: K092324(SPECIAL)
ASCEND
NEUROMETRIX, INC.
510(k) NO: K091155(TRADITIONAL)
ICS CHARTR EP 200
GN OTOMETRICS
510(k) NO: K092373(SPECIAL)
STRONG IMPLANT HANDPIECES
SAESHIN PRECISION CO., LTD.
510(k) NO: K092412(TRADITIONAL)
YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
JIANGSU YUYUE MEDICAL EQUIPMENT &
510(k) NO: K083559(TRADITIONAL)
TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M
TRULY INSTRUMENT CO., LTD.
510(k) NO: K091415(ABBREVIATED)
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
CONVATEC, A DIVISION OF E.R. SQUIB
510(k) NO: K090254(TRADITIONAL)
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
BIOSENSE WEBSTER, INC.
510(k) NO: K090898(SPECIAL)
ATLAS SPINE SPACER
ATLAS SPINE LLC
510(k) NO: K091406(TRADITIONAL)
CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12
BONESUPPORT AB
510(k) NO: K090871(TRADITIONAL)
EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS
ETHICON ENDO-SUGERY, LLC
510(k) NO: K091211(TRADITIONAL)
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
TRULY INSTRUMENT CO., LTD.
510(k) NO: K091434(ABBREVIATED)
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
HARTALEGA SDN BHD
510(k) NO: K091652(TRADITIONAL)
UCP HOME DRUG SCREENING TESTS
UCP BIOSCIENCES, INC.
510(k) NO: K091588(TRADITIONAL)
CLEARVIEW ADVANCED STREP A , MODEL 737-430
BINAX, INC.
510(k) NO: K091489(TRADITIONAL)
GEM HEART ONE/ONE+
GEM-MED S.L.
510(k) NO: K092576(TRADITIONAL)
INREACH SYSTEM, MODEL AAS00161-02
SUPERDIMENSION, LTD.
510(k) NO: K092365(SPECIAL)
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
SPECTRANETICS CORP.
510(k) NO: K092396(SPECIAL)
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
INVIRO MEDICAL DEVICES, INC.
510(k) NO: K092413(SPECIAL)
CLO-SURPLUS P.A.D.
SCION CARDIO-VASCULAR, INC.
510(k) NO: K092552(TRADITIONAL)
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
INVIRO MEDICAL DEVICES, INC.
510(k) NO: K092430(SPECIAL)
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
BOSTON SCIENTIFIC CORPORATION
510(k) NO: K092455(SPECIAL)
MODIFICATION TO SI JOINT FUSION SYSTEM
SI-BONE, INC.
510(k) NO: K092375(SPECIAL)
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
MEDICA CORP.
510(k) NO: K091991(SPECIAL)
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
FUJIREBIO DIAGNOSTICS, INC.
510(k) NO: K092645(TRADITIONAL)
DOCTOR SMILE A-810 AND B-980 LASERS
LAMBDA SCIENTIFIC SPA
510(k) NO: K091562(ABBREVIATED)
ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)
ANGLEFIX
510(k) NO: K091619(TRADITIONAL)
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
CODMAN & SHURTLEFF, INC.
510(k) NO: K091921(SPECIAL)
SPINAL FORAMINOSCOPE
BLAZEJEWSKI MEDI-TECH GMBH
510(k) NO: K082841(TRADITIONAL)
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
DIASORIN, INC.
510(k) NO: K090104(TRADITIONAL)
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
ALFA WASSERMANN, INC.
510(k) NO: K091544(TRADITIONAL)
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
CONFORMIS, INC.
510(k) NO: K092441(SPECIAL)
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
OBP CORPORATION
510(k) NO: K091937(TRADITIONAL)
NSM-S15 SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD.
510(k) NO: K092237(TRADITIONAL)
UNITY BETA PLLA SYSTEM
BONUTTI RESEARCH, INC.
510(k) NO: K090175(TRADITIONAL)
OSTEOMED FOOT PLATING SYSTEM
OSTEOMED L.P.
510(k) NO: K091614(TRADITIONAL)
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
HANSEN MEDICAL, INC.
510(k) NO: K091808(SPECIAL)
BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205
REFRACTRON TECHNOLOGIES CORP.
510(k) NO: K091852(TRADITIONAL)
ALCATEL-LUCENT TELEHEATH MANAGER
ALCATEL-LUCENT CANADA INC.
510(k) NO: K092635(TRADITIONAL)
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
CARDIAC SCIENCE CORPORATION
510(k) NO: K091943(SPECIAL)
COMFORT TWIN NASAL MASK
RESPIRONICS INC., SLEEP & HOME RES
510(k) NO: K091843(TRADITIONAL)
VALLEYLAB SUCTION COAGULATOR, MODEL E3305
COVIDIEN LP
510(k) NO: K091223(TRADITIONAL)
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
URIT MEDICAL ELECTRONIC CO., LTD.
510(k) NO: K082811(TRADITIONAL)
DENSICHEK PLUS
BIOMERIEUX, INC.
510(k) NO: K083536(TRADITIONAL)
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
UROVAL
510(k) NO: K083679(TRADITIONAL)
VF LIQUIGEL
COAPT SYSTEMS, INC.
510(k) NO: K083783(TRADITIONAL)
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
DIAGNOSTIC HYBRIDS, INC.
510(k) NO: K091171(TRADITIONAL)
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
ZIMMER, INC.
510(k) NO: K091799(TRADITIONAL)
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
ZIMMER, INC.
510(k) NO: K091508(TRADITIONAL)
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
BACTERIN INTERNATIONAL INC.
510(k) NO: K091321(TRADITIONAL)
HEARTRAIL III GUIDING CATHETER
TERUMO CORP.
510(k) NO: K092372(TRADITIONAL)
TRU FLU, MODEL 751230
MERIDIAN BIOSCIENCE, INC.
510(k) NO: K092553(SPECIAL)
IST SNORING APPLIANCE
DENTAL CRAFTERS
510(k) NO: K090911(TRADITIONAL)
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
VASCULAR SOLUTIONS, INC.
510(k) NO: K092612(SPECIAL)
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
SMITH & NEPHEW, INC.
510(k) NO: K092497(SPECIAL)
RUTTER SUPRA STOMAL STENTS
BOSTON MEDICAL PRODUCTS, INC.
510(k) NO: K091135(TRADITIONAL)
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW
CO-LIGNE AG
510(k) NO: K083567(SPECIAL)
TSI; ERI
OCO BIOMEDICAL
510(k) NO: K090174(TRADITIONAL)
GRACE DYNAMIC TORP
GRACE MEDICAL, INC.
510(k) NO: K091187(TRADITIONAL)
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
SPINEFRONTIER, INC.
510(k) NO: K091638(ABBREVIATED)
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
FOOTPRINT MEDICAL
510(k) NO: K091488(TRADITIONAL)
MODIFICATION TO: PSS SYSTEM
SPINAL USA
510(k) NO: K092128(SPECIAL)
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) NO: K091968(TRADITIONAL)
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
ETHICON ENDO-SURGERY, LLC
510(k) NO: K092577(TRADITIONAL)
BELTBEAT WF-400
BONUS COMMUNICACIONES SRL
510(k) NO: K083715(TRADITIONAL)
ESTECH HAWKEYE INTRODUCER SYSTEMS
ENDOSCOPIC TECHNOLOGIES, INC. D/B/
510(k) NO: K091350(TRADITIONAL)
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
STATRAD, LLC
510(k) NO: K092134(TRADITIONAL)
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
CARDINAL HEALTH, INC.
510(k) NO: K092304(TRADITIONAL)
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
ISOAID, L.L.C.
510(k) NO: K091117(TRADITIONAL)
QUICKVUE INFLUENZA A+B TEST
QUIDEL CORP.
510(k) NO: K092698(SPECIAL)
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
FLEXIBLE STENTING SOLUTIONS, INC.
510(k) NO: K081996(TRADITIONAL)
MODEL 1014 PC ELECTROMETER
SUN NUCLEAR CORP.
510(k) NO: K092019(TRADITIONAL)
FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
BEERE PRECISION MEDICAL INSTRUMENT
510(k) NO: K092533(SPECIAL)
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
GX CORPORATION SDN BHD
510(k) NO: K092200(TRADITIONAL)
M. DIOR BRAND
SUZHOU COLOUR-WAY ENTERPRISE DEVEL
510(k) NO: K083817(ABBREVIATED)
WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,
MEDSHAPE SOLUTIONS
510(k) NO: K091202(TRADITIONAL)
ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
ACE SURGICAL SUPPLY CO., INC.
510(k) NO: K092594(SPECIAL)
POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG ELEGANCE PLASTIC PROD
510(k) NO: K092416(TRADITIONAL)
STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
DANVILLE MATERIALS, INC.
510(k) NO: K092319(TRADITIONAL)
PRO-PICC
MEDCOMP
510(k) NO: K091953(TRADITIONAL)
PRO-PICC CT
MEDCOMP
510(k) NO: K092347(SPECIAL)
EASYRA GLU-H REAGENT, MODEL 10200
MEDICA CORP.
510(k) NO: K092506(SPECIAL)
COBALT MV BONE CEMENT
BIOMET MANUFACTURING CORP.
510(k) NO: K091608(TRADITIONAL)
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
STERIS CORPORATION
510(k) NO: K091731(ABBREVIATED)
ESOPHAGEAL STETHOSCOPE
TRUER MEDICAL INC.
510(k) NO: K092716(TRADITIONAL)
DEVICE: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
TANGSHAN HONGXING PLASTIC PRODUCTS
510(k) NO: K092100(TRADITIONAL)
COLLAGEN DENTAL MEMBRANE IV
COLLAGEN MATRIX, INC.
510(k) NO: K090216(TRADITIONAL)
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
ACCURAY, INC.
510(k) NO: K091999(SPECIAL)
NUNC IVF CENTERWELL AND ICSI DISHES
THERMO FISHER SCIENTIFIC (NALGE NU
510(k) NO: K090429(TRADITIONAL)
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
ETEX CORP.
510(k) NO: K090855(TRADITIONAL)
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
MICROGENICS CORP.
510(k) NO: K090810(TRADITIONAL)
CFI ULTRASOUND PROBE DRAPE
CONTOUR FABRICATORS, INC.
510(k) NO: K090773(TRADITIONAL)
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
GISH BIOMEDICAL, INC.
510(k) NO: K090449(TRADITIONAL)
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
GISH BIOMEDICAL, INC.
510(k) NO: K090450(TRADITIONAL)
MARKSMANN CATHETER
CHESTNUT MEDICAL TECHNOLOGIES, INC
510(k) NO: K091559(TRADITIONAL)
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
SAMSUNG MOBILE DISPLAY CO., LTD
510(k) NO: K090742(TRADITIONAL)
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
OLYMPUS MEDICAL SYSTEMS CORPORATIO
510(k) NO: K091759(TRADITIONAL)
LIGHTLAS MODEL 532
LIGHTMED CORP.
510(k) NO: K091534(TRADITIONAL)
DIANA FUSION CAGE
SIGNUS MEDICAL
510(k) NO: K091122(TRADITIONAL)
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
TAIDOC TECHNOLOGY CORPORATION
510(k) NO: K091898(SPECIAL)
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
SHANGDONG ZIBO SHANCHUAN MEDICAL I
510(k) NO: K092000(TRADITIONAL)
POGO SCREW
FXDEVICES
510(k) NO: K092189(SPECIAL)
DIGITAL BLOOD PRESSURE MONITOR
SHANGHAI LITTLE DOCTOR ELECTRONIC
510(k) NO: K092719(TRADITIONAL)
160MLC OPTION
SIEMENS MEDICAL SOLUTIONS USA, INC
510(k) NO: K092145(TRADITIONAL)
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
MEDCOM GMBH
510(k) NO: K092653(SPECIAL)
COPRAN ZR/ORIGIN YZ
WHITE PEAKS DENTAL SYSTEMS GMBH &
510(k) NO: K092496(TRADITIONAL)
OMNIPRO INCLINE
IBA DOSIMETRY GMBH
510(k) NO: K092018(TRADITIONAL)
TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S
SPINEART
510(k) NO: K091873(ABBREVIATED)
LED CURING LIGHT, MODEL GT-1500
MONITEX INDUSTRIAL CO., LTD.
510(k) NO: K091887(TRADITIONAL)
ABVS WORKPLACE
SIEMENS AG, MEDICAL SOLUTIONS
510(k) NO: K092067(TRADITIONAL)
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
HOSPIRA, INC.
510(k) NO: K091268(SPECIAL)
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
CEPHEID
510(k) NO: K082118(TRADITIONAL)
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
FHC, INC.
510(k) NO: K092562(SPECIAL)
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
ZIBO INTCO MEDICAL PRODUCTS CO., L
510(k) NO: K091942(TRADITIONAL)
HEALTHANYWHERE SYSTEM
HEALTHANYWHERE, AN IGEACARE SYSTEM
510(k) NO: K091220(TRADITIONAL)
INJECTAFIL
APEX DENTAL MATERIALS, INC.
510(k) NO: K091647(TRADITIONAL)
RASCAL “WE GO 250“ POWERED WHEELCHAIR
ELECTRIC MOBILITY CORP.
510(k) NO: K092130(ABBREVIATED)
BELLUS SHADING KIT
3M ESPE AG DENTAL PRODUCTS
510(k) NO: K090718(TRADITIONAL)
HEARTWAY POWER MOBILITY SCOOTER, S9
HEARTWAY MEDICAL PRODUCTS CO., LTD
510(k) NO: K092154(TRADITIONAL)
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
MICROGENICS CORP.
510(k) NO: K092051(TRADITIONAL)
HEARTWAY POWER MOBILITY SCOOTER, S8
HEARTWAY MEDICAL PRODUCTS CO., LTD
510(k) NO: K092155(TRADITIONAL)
PERSONAL WHEEZOMETER
KARMELSONIX
510(k) NO: K090863(TRADITIONAL)
TORNIER, PITON FIXATION IMPLANT SYSTEM
TORNIER
510(k) NO: K091870(TRADITIONAL)
T2 SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC.
510(k) NO: K091883(TRADITIONAL)
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
PENUMBRA, INC.
510(k) NO: K090752(TRADITIONAL)
BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
NINGBO DIAIER ELECTRONIC CO., LTD.
510(k) NO: K091553(TRADITIONAL)
X-CUBE
SAESHIN PRECISION CO., LTD.
510(k) NO: K092758(TRADITIONAL)
MICRO-TOUCH NITRA FREE
ANSELL HEALTHCARE PRODUCTS LLC
510(k) NO: K092327(ABBREVIATED)
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
NSPIRE HEALTH, INC.
510(k) NO: K091853(TRADITIONAL)
DISPOSABLE SPO2 SENSOR M1134A
PHILIPS MEDIZINSYSTEME BOEBLINGEN
510(k) NO: K091572(TRADITIONAL)
MRI NEURO DRAPE
SURGIVISION, INC.
510(k) NO: K091343(TRADITIONAL)
EXTEND FRAME SYSTEM, MODEL 1009633
ELEKTA INSTRUMENT AB
510(k) NO: K092083(TRADITIONAL)
NOBELPROCERA TI ABUTMENT
NOBEL BIOCARE AB
510(k) NO: K091756(TRADITIONAL)
ASTRA TECH IMPLANT SYSTEM
ASTRA TECH AB
510(k) NO: K091239(TRADITIONAL)
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD.
510(k) NO: K092742(TRADITIONAL)
ACL TOP 700 LAS
INSTRUMENTATION LABORATORY CO.
510(k) NO: K091980(SPECIAL)
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
EV3 NEUROVASCULAR
510(k) NO: K092495(SPECIAL)
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
AESCULAP IMPLANT SYSTEMS, INC.
510(k) NO: K092143(SPECIAL)
LIPOEZE LASER ASSISTED ASPIRATION CANNULA
CURVE MEDICAL
510(k) NO: K091800(TRADITIONAL)
VARIAX ELBOW SYSTEM LINE EXTENSION
HOWMEDICA OSTEONICS CORP.
510(k) NO: K092671(SPECIAL)
BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2
BELIMED SAUTER AG
510(k) NO: K090339(TRADITIONAL)
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
ZOLL MEDICAL CORP.
510(k) NO: K090989(TRADITIONAL)
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB
ANCHOR PRODUCTS CO.
510(k) NO: K091930(SPECIAL)
VESOCCLUDE LIGATING CLIP
VESOCCLUDE MEDICAL, LLC
510(k) NO: K091060(TRADITIONAL)
APTUS K-WIRE SYSTEM
MEDARTIS AG
510(k) NO: K092038(TRADITIONAL)
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN
GE HEALTHCARE FINLAND OY
510(k) NO: K092680(SPECIAL)
LAURIMED SPINAL INJECTION SYSTEM
LAURIMED LLC
510(k) NO: K091818(SPECIAL)
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
STETHOSCOPE TECHNOLOGIES, INC
510(k) NO: K091972(TRADITIONAL)
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000
NEXGEN MEDICAL SYSTEMS, INC.
510(k) NO: K090932(TRADITIONAL)
PACSCAN PLUS, MODELS 300P AND 300AP
SONOMED, INC.
510(k) NO: K092637(SPECIAL)
XIO RTP SYSTEM
COMPUTERIZED MEDICAL SYSTEMS, INC.
510(k) NO: K092132(TRADITIONAL)
MODIFICATION TO BEACON STABILIZATION SYSTEM
GLOBUS MEDICAL, INC.
510(k) NO: K092610(SPECIAL)
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
PROCTER & GAMBLE CO.
510(k) NO: K091964(TRADITIONAL)
RP CUTTING NEEDLE
RIVERPOINT MEDICAL
510(k) NO: K092059(TRADITIONAL)
PASCAL STREAMLINE PHOTOCOAGULATOR
OPTIMEDICA CORPORATION
510(k) NO: K092621(SPECIAL)
FIREBIRD SPINAL FIXATION SYSTEM
BLACKSTONE MEDICAL, INC.
510(k) NO: K092624(SPECIAL)
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
TANGSHAN DAR PLASTIC & RUBBER PROD
510(k) NO: K082648(TRADITIONAL)
BIOMET MODULAR FEMORAL REVISION SYSTEM
BIOMET, INC.
510(k) NO: K090757(TRADITIONAL)
CONDUCTOR CORONARY GUIDEWIRE
CONCERT MEDICAL, LLC
510(k) NO: K090193(TRADITIONAL)
ALPHA DUO LAP INSUFFLATOR
HIPPOKRATEC GMBH
510(k) NO: K090652(TRADITIONAL)
SONOWAND INVITE
SONOWAND AS
510(k) NO: K083597(TRADITIONAL)
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
AXIS-SHIELD DIAGNOSTICS, LTD.
510(k) NO: K083868(TRADITIONAL)
ELEGANT
3M ESPE AG DENTAL PRODUCTS
510(k) NO: K091826(TRADITIONAL)
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
ABBOTT VASCULAR INC.
510(k) NO: K091825(TRADITIONAL)
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
MAXX ORTHOPEDICS, INC.
510(k) NO: K091280(TRADITIONAL)
ELECYS ANTI-CCP CALCHECK
ROCHE DIAGNOSTICS CORP.
510(k) NO: K091601(TRADITIONAL)
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
FOOTPRINT MEDICAL
510(k) NO: K091213(TRADITIONAL)
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
FOOTPRINT MEDICAL
510(k) NO: K091214(TRADITIONAL)
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT
S & C POLYMER GMBH
510(k) NO: K091735(TRADITIONAL)
KNEEALIGN SYSTEM
ORTHALIGN, INC
510(k) NO: K091411(TRADITIONAL)
SPI CUSTOMIZABLE GINGIVA FORMER
THOMMEN MEDICAL, AG
510(k) NO: K092248(SPECIAL)
MODIFICATION TO: EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC.
510(k) NO: K092626(SPECIAL)
SNM FIRMGRIP
FLEXICATH LTD.
510(k) NO: K092629(SPECIAL)
SYNTHES LOCKING HAND PLATES
SYNTHES (USA)
510(k) NO: K092247(TRADITIONAL)
OSOM INFLUENZA A&B TEST , MODEL PN190
GENZYME CORPORATION
510(k) NO: K092633(SPECIAL)
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
STRYKER SPINE
510(k) NO: K091946(TRADITIONAL)
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
SYNTHES (USA)
510(k) NO: K092646(TRADITIONAL)
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG ELEGANCE PLASTIC PROD
510(k) NO: K092415(TRADITIONAL)
MANTIS REDUX SPINAL SYSTEM
STRYKER SPINE
510(k) NO: K092631(SPECIAL)
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
PRIMED MEDICAL PRODUCTS INC.
510(k) NO: K092012(SPECIAL)
NOBELPROCERA ZI ABUTMENT
NOBEL BIOCARE AB
510(k) NO: K091904(TRADITIONAL)
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
SHANGHAI LITTLE DOCTOR CO. LIMITED
510(k) NO: K092683(SPECIAL)
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
COOK ENDOSCOPY
510(k) NO: K090183(SPECIAL)
SPINAL USA INTERBODY CAGES
SPINAL USA
510(k) NO: K092193(TRADITIONAL)
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
MSI MEDSERV INTERNATIONAL DEUTSCHL
510(k) NO: K083840(TRADITIONAL)
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
GIVEN IMAGING LTD.
510(k) NO: K090557(TRADITIONAL)
KAINOS+
SIGNUS MEDIZINTECHNIK GMBH
510(k) NO: K090387(TRADITIONAL)
SHEATHESISO ULTRASOUND TRANSDUCER COVER
SHEATHING TECHNOLOGIES, INC.
510(k) NO: K091828(TRADITIONAL)
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
TRANSENTERIX, INC.
510(k) NO: K091697(TRADITIONAL)
SPINEWAND SURGICAL DEVICE
ARTHROCARE CORP.
510(k) NO: K091228(SPECIAL)
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
LIGHTMED CORP.
510(k) NO: K091981(TRADITIONAL)
DBX DEMINERALIZED BONE MATRIX PUTTY
MUSCULOSKELETAL TRANSPLANT FOUNDAT
510(k) NO: K091218(TRADITIONAL)
DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST
SUNRISE MEDICAL
510(k) NO: K091919(TRADITIONAL)
S8 ASPEN WITH H4I PLUS
RESMED LTD.
510(k) NO: K091947(TRADITIONAL)
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
GE VINGMED ULTRASOUND AS
510(k) NO: K092756(TRADITIONAL)
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
MAKO SURGICAL CORP.
510(k) NO: K091998(TRADITIONAL)
IROOT BP PLUS
INNOVATIVE BIOCERAMIX INC.
510(k) NO: K092715(SPECIAL)
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
TRUMPF MEDIZIN SYSTEME GMBH + CO.
510(k) NO: K091246(ABBREVIATED)
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL
ASTRA TECH, INC.
510(k) NO: K091920(TRADITIONAL)
SYNERGY
INNERSPACE, INC.
510(k) NO: K083378(SPECIAL)
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
AUTOSAFE-REFLEX INC.
510(k) NO: K090117(ABBREVIATED)
PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK
510(k) NO: K090353(TRADITIONAL)
HS AMICA
H.S HOSPITAL SERVICE S.P.A.
510(k) NO: K083157(TRADITIONAL)
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
CORPAK MEDSYSTEMS
510(k) NO: K091637(TRADITIONAL)
JOURNEY BCS KNEE SYSTEM
SMITH & NEPHEW, INC.
510(k) NO: K091014(TRADITIONAL)
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
GYRUS ACMI, INC.
510(k) NO: K092278(TRADITIONAL)
AADVA ZR COLORING LIQUID
GC AMERICA INC.
510(k) NO: K092020(TRADITIONAL)
MODEL GDCH-2000
GLOBAL DENTAL DIRECT, INC.
510(k) NO: K092851(TRADITIONAL)
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
LUMENIS, INC.
510(k) NO: K091962(TRADITIONAL)
PARCUS PPEK CF INTERFERENCE SCREW
PARCUS MEDICAL, LLC
510(k) NO: K091093(TRADITIONAL)
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
PARCUS MEDICAL, LLC
510(k) NO: K091094(TRADITIONAL)
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
HEALTH & LIFE CO., LTD.
510(k) NO: K092161(TRADITIONAL)
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
EMBLA MEDICAL, INC.
510(k) NO: K092003(TRADITIONAL)
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
BOSTON SCIENTIFIC CORP.
510(k) NO: K092666(SPECIAL)