S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
ALFA WASSERMANN, INC.
510(k) NO: K091333 (TRADITIONAL)

VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
VISION-SCIENCES, INC.
510(k) NO: K091768 (TRADITIONAL)

ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
ARTHREX, INC.
510(k) NO: K083707 (TRADITIONAL)

AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION
510(k) NO: K083097 (TRADITIONAL)

QUATTRO LT
RESMED LTD.
510(k) NO: K091129 (TRADITIONAL)

LIFECARE ELECTRODES
EVERYWAY MEDICAL INSTRUMENTS CO.,
510(k) NO: K083302 (TRADITIONAL)

REMSTAR AUTO A-FLEX
RESPIRONICS INC., SLEEP & HOME RES
510(k) NO: K091319 (TRADITIONAL)

BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
C.R. BARD, INC.
510(k) NO: K091659 (TRADITIONAL)

MODIFICATION TO: DSS STABILIZATION SYSTEM
PARADIGM SPINE, LLC
510(k) NO: K091944 (SPECIAL)

RESTORELLE POLYPROPYLENE MESH
MPATHY MEDICAL DEVICES INC
510(k) NO: K092207 (SPECIAL)

EZC MEDICAL, LLC INTUBAIDFLEX
EZC MEDICAL, LLC
510(k) NO: K090777 (TRADITIONAL)

MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
GISH BIOMEDICAL, INC.
510(k) NO: K091062 (TRADITIONAL)

RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
RESTORATIVE THERAPIES INC.
510(k) NO: K090750 (TRADITIONAL)

NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
CONMED INTEGRATED SYSTEMS (CMIS)
510(k) NO: K091648 (TRADITIONAL)

CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM
CARDO MEDICAL CORP.
510(k) NO: K091396 (TRADITIONAL)

OPTILOCK PERIARTICULAR PLATING
BIOMET TRAUMA
510(k) NO: K092078 (SPECIAL)

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
VIRAMED BIOTECH AG
510(k) NO: K082329 (TRADITIONAL)

BIPAP SYNCHRONY 2
RESPIRONICS, INC.
510(k) NO: K092043 (SPECIAL)

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
ABBOTT LABORATORIES INC
510(k) NO: K090358 (TRADITIONAL)

MONTERIS MEDICAL UFO
MONTERIS MEDICAL
510(k) NO: K090240 (TRADITIONAL)

MINI TIGHTROPE
ARTHREX, INC.
510(k) NO: K090107 (TRADITIONAL)

VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
MEDTRONIC SOAFAMOR DANEK
510(k) NO: K091365 (TRADITIONAL)

ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
AMERICAN BIOLOGICAL TECHNOLOGIES,
510(k) NO: K091460 (TRADITIONAL)

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
SIEMENS HEALTHCARE DIAGNOSTICS
510(k) NO: K091289 (TRADITIONAL)

SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES
SHINA CORP.
510(k) NO: K091167 (TRADITIONAL)

MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
GE MEDICAL SYSTEMS ISRAEL, ULTRASO
510(k) NO: K092079 (SPECIAL)

BEYONDIMAGE WORKSTATION
NEUSOFT MEDICAL SYSTEMS CO., LTD.
510(k) NO: K092235 (TRADITIONAL)

SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
BIOSENSE WEBSTER, INC.
510(k) NO: K092064 (SPECIAL)

EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
EUROIMMUN US INC
510(k) NO: K083053 (TRADITIONAL)

BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC)
BOVIE MEDICAL
510(k) NO: K090586 (TRADITIONAL)

VERIFY 275F GRAVITY INDICATORS
STERIS CORPORATION
510(k) NO: K083643(ABBREVIATED)

ECOCEL
POLICHEM S.A.
510(k) NO: K083087 (TRADITIONAL)

I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT
WEIHAI JIERUI MEDICAL PRODUCTS CO.
510(k) NO: K083429 (TRADITIONAL)

KOWA, FM-600, MODEL LSS50
KOWA CO. LTD.
510(k) NO: K091039 (TRADITIONAL)

SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
C.R. BARD, INC.
510(k) NO: K091324 (TRADITIONAL)

KOWAGENESIS-DF
KOWA CO. LTD.
510(k) NO: K091098 (TRADITIONAL)

IBEX SPINAL SYSTEM
EBI, L.P.
510(k) NO: K091381 (TRADITIONAL)

RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS
DEPUY MITEK, A JOHNSON & JOHNSON C
510(k) NO: K091041 (TRADITIONAL)

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
AMCO INTERNATIONAL MANUFACTURING &
510(k) NO: K091548 (TRADITIONAL)

PHARMAPAC PERSONAL LUBRICANT
PHARMAPAC LLC
510(k) NO: K091554 (TRADITIONAL)

PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
ISORAY MEDICAL, INC.
510(k) NO: K092136 (SPECIAL)

CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
CRYOLIFE, INC.
510(k) NO: K091626 (TRADITIONAL)

TEPHAFLEX SURGICAL FILM
TEPHA, INC.
510(k) NO: K091633 (TRADITIONAL)

CDB FLIP-SIDE-CLIP BRACKET
CDB CORPORATION
510(k) NO: K091702 (TRADITIONAL)

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
COOK, INC.
510(k) NO: K091385 (SPECIAL)

FUJINON STERILE OVERTUBES
FUJINON, INC.
510(k) NO: K091773 (SPECIAL)

HORIZON XVU
MENNEN MEDICAL LTD.
510(k) NO: K091165 (TRADITIONAL)

CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
CONMED CORPORATION
510(k) NO: K091856 (SPECIAL)

DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
CENTURY PHARMACEUTICALS, INC.
510(k) NO: K090791 (TRADITIONAL)

EN SNARE ENDOVASCULAR SNARE SYSTEM
MERIT MEDICAL SYSTEMS, INC.
510(k) NO: K092343 (TRADITIONAL)

CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
ST. JUDE MEDICAL, CARDIAC RHYTHM M
510(k) NO: K092075 (SPECIAL)

SIGNAL
ZARGIS MEDICAL CORP.
510(k) NO: K090493 (TRADITIONAL)

MONOPOLY PEDICLE SCREW SYSTEM
SIGNUS MEDICAL
510(k) NO: K092073 (SPECIAL)

ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
BAXTER HEALTHCARE CORP.
510(k) NO: K090002 (TRADITIONAL)

TRAILBLAZER SUPPORT CATHETER
EV3 INC
510(k) NO: K092299 (TRADITIONAL)

LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
ALLEZ SPINE, LLC
510(k) NO: K091995 (SPECIAL)

GDX VCC WITH ECC SOFTWARE
CARL ZEISS MEDITEC INC.
510(k) NO: K082016 (TRADITIONAL)

SONIC AIR MM1500 + (MID), MODEL 50400014
MICRO-MEGA SOCIETE ANONYME
510(k) NO: K081268 (TRADITIONAL)

SCALAR WAVE LASER SYSTEM
STELLAR LASERS
510(k) NO: K091158 (TRADITIONAL)

UC-CARE WARMING SYSTEM
UC-CARE LTD.
510(k) NO: K090978 (TRADITIONAL)

MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
MASIMO CORPORATION
510(k) NO: K090662 (TRADITIONAL)

MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
KIMBERLY-CLARK CORP.
510(k) NO: K091357(ABBREVIATED)

ACCELL EVO3C
ISOTIS ORTHOBIOLOGICS, INC
510(k) NO: K091193 (TRADITIONAL)

POWERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG CENTURY PLASTIC CO.,
510(k) NO: K091521 (TRADITIONAL)

AMSURE HYDROPHILIC LATEX FOLEY CATHETER
AMSINO INTERNATIONAL, INC.
510(k) NO: K091699 (SPECIAL)

ZOOM-100DC
BRAINSCOPE COMPANY, INC.
510(k) NO: K082886 (TRADITIONAL)

JIAJIAN ACUPUNCTURE NEEDLE
WUXI JIAJIAN MEDICAL INSTRUMENT CO
510(k) NO: K090199 (TRADITIONAL)

POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
SOPHYSA SA
510(k) NO: K090342 (TRADITIONAL)

DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
SPES MEDICA S.R.L.
510(k) NO: K091410 (TRADITIONAL)

PROTEUS 235 PROTON THERAPY SYSTEM
ION BEAM APPLICATIONS S.A.
510(k) NO: K091629 (TRADITIONAL)

SENTINEL SPINAL SYSTEM
LIFE SPINE
510(k) NO: K090343 (TRADITIONAL)

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
AGFA HEALTHCARE N.V.
510(k) NO: K092238 (TRADITIONAL)

SWITCH TRT
AUDIFON GMBH & CO. KG
510(k) NO: K091552(ABBREVIATED)

FOOTPRINT URINARY DRAINAGE CATHETER
FOOTPRINT MEDICAL
510(k) NO: K090576 (TRADITIONAL)

INVISION SYSTEM
INNEROPTIC TECHNOLOGY, INC
510(k) NO: K083728 (TRADITIONAL)

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
TANGSHAN ZHONGPU PLASTIC PRODUCTS
510(k) NO: K090551 (TRADITIONAL)

HDR PROSTATE TEMPLATE AND ACCESSORIES
PHOTON TECHNOLOGIES CORPORATION
510(k) NO: K091230 (TRADITIONAL)

LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
DEPUY ORTHOPAEDICS, INC.
510(k) NO: K091453 (TRADITIONAL)

NIPRO DISPOSABLE SYRINGE
NIPRO MEDICAL CORPORATION
510(k) NO: K091279 (SPECIAL)

TANSCU O2
ELECTROCHEMICAL OXYGEN CONCEPTS, I
510(k) NO: K090681(ABBREVIATED)

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
SORIN GROUP ITALIA S.R.L.
510(k) NO: K092315 (SPECIAL)

AIXPLORERE, MODEL P90001-01A
SUPERSONIC IMAGINE
510(k) NO: K091970 (TRADITIONAL)

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
BINAX, INC.
510(k) NO: K092223 (SPECIAL)

OMNISURE URETHRAL SLING, MODEL OTK52
MPATHY MEDICAL DEVICES, LTD.
510(k) NO: K092203 (SPECIAL)

UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
IMPACT INSTRUMENTATION, INC.
510(k) NO: K091238 (TRADITIONAL)

ANOVA CONTAINMENT DEVICE
ANOVA CORPORATION
510(k) NO: K063461 (TRADITIONAL)

G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
GYRUS ACMI, INC.
510(k) NO: K080844 (TRADITIONAL)

ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
PURNABINA SDN BHD
510(k) NO: K083571 (TRADITIONAL)

TROPAZONE LOTION
MIDLOTHIAN LABORATORIES
510(k) NO: K090337 (TRADITIONAL)

CHROMA, MODEL: RZ153C
SCOTTCARE CORPORATION
510(k) NO: K083382 (TRADITIONAL)

TT-102
TISSUE TECHNOLOGIES HOLDINGS, LLC
510(k) NO: K081246 (TRADITIONAL)

IMM DENTAL IRRIGATION TUBING SET
INNOVATIVE MEDICAL MANUFACTURING C
510(k) NO: K090727 (TRADITIONAL)

HELIO2 BLENDER
PRECISION MEDICAL, INC.
510(k) NO: K090781 (TRADITIONAL)

FOXQ 980 LASER
A.R.C. LASER GMBH
510(k) NO: K091059 (TRADITIONAL)

REVERE 6.35 STABILIZATION SYSTEM
GLOBUS MEDICAL INC.
510(k) NO: K091782 (SPECIAL)

LIGHTLAS SELECTOR
LIGHTMED CORP.
510(k) NO: K090774 (TRADITIONAL)

TRUSS THORACOLUMBAR PLATE SYSTEM
GLOBUS MEDICAL, INC.
510(k) NO: K092108 (SPECIAL)

ALMA LASERS ALEX755 MODULE
ALMA LASERS LTD.
510(k) NO: K090571 (TRADITIONAL)

MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
INSTRATEK, INC.
510(k) NO: K091763 (SPECIAL)

SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
BECKMAN COULTER, INC.
510(k) NO: K091742 (TRADITIONAL)

SCANSCOPE XT SYSTEM
APERIO TECHNOLOGIES
510(k) NO: K080564 (TRADITIONAL)

LENSX 550 LASER SYSTEM
LENSX LASERS, INC.
510(k) NO: K082947 (TRADITIONAL)

SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
THE ELECTRODE STORE, INC.
510(k) NO: K083758 (TRADITIONAL)

ASFORA BULLET CAGE SYSTEM
MEDICAL DESIGNS, LLC
510(k) NO: K090048 (TRADITIONAL)

MODIFICATION TO: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK
510(k) NO: K090740 (SPECIAL)

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
ARKRAY FACTORY USA, INC.
510(k) NO: K090332 (TRADITIONAL)

DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
DIAZYME LABORATORIES
510(k) NO: K091455 (TRADITIONAL)

ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
SIEMENS HEALTHCARE DIAGNOSTICS
510(k) NO: K091123(ABBREVIATED)

VITEK 2 GRAM NEGATIVE MEROPENEM
BIOMERIEUX, INC.
510(k) NO: K091899 (TRADITIONAL)

B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
B. BRAUN MEDICAL, INC.
510(k) NO: K090995 (TRADITIONAL)

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
CARDIOPULMONARY CORP.
510(k) NO: K091461 (TRADITIONAL)

MEDI-6000 MEDICAL IMAGE DIGITIZER
MICROTEK INTERNATIONAL, INC.
510(k) NO: K091288 (TRADITIONAL)

PATHFAST CK-MM-II, PATHFAST MYO-II
MITSUBISHI KAGAKU IATRON
510(k) NO: K081360 (TRADITIONAL)

SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
GARRISON DENTAL SOLUTIONS
510(k) NO: K091533 (TRADITIONAL)

CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
CUSTOM SPINE, INC.
510(k) NO: K091134 (TRADITIONAL)

TISSU TRANS HARVEST TUBING
SHIPPERT MEDICAL TECHNOLOGIES CORP
510(k) NO: K092022(SPECIAL)

AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
ENCISION, INC.
510(k) NO: K091074 (TRADITIONAL)

BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
BIOMET TRAUMA
510(k) NO: K091976 (TRADITIONAL)

S. AUREUS PNA FISH
ADVANDX, INC.
510(k) NO: K091827 (TRADITIONAL)

DISPOSABLE PRESSURE TRANSDUCER
SHENZHEN ANT HI-TECH INDUSTRIAL CO
510(k) NO: K091408 (TRADITIONAL)

PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
SMITHS MEDICAL ASD, INC.
510(k) NO: K083031 (TRADITIONAL)

NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
AA NEUROMED CORP.
510(k) NO: K083250 (TRADITIONAL)

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
AIR TECHNIQUES, INC.
510(k) NO: K090169 (TRADITIONAL)

EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.
510(k) NO: K091481 (SPECIAL)

SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
ANDON HEALTH CO.,LTD
510(k) NO: K091738 (SPECIAL)

SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
ANDON HEALTH CO.,LTD
510(k) NO: K091739 (SPECIAL)

KODAK 1500 INTRAORAL CAMERA
CARESTREAM HEALTH, INC.
510(k) NO: K091186 (TRADITIONAL)

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
ANDON HEALTH CO.,LTD
510(k) NO: K091737 (SPECIAL)

KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) NO: K090818 (TRADITIONAL)

ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
ROCHE DIAGNOSTICS
510(k) NO: K082699 (TRADITIONAL)

SPECTRA SP II, SPECTRA DENTA II
LUTRONIC CORPORATION
510(k) NO: K091320 (TRADITIONAL)

CONTURA CAVITY MAINTENANCE CATHETER
SENORX, INC.
510(k) NO: K092323 (TRADITIONAL)

K-LASER K-1200, MODEL 12 W
ELTECH, S.R.L.
510(k) NO: K091497 (TRADITIONAL)

MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
PURICORE INC.
510(k) NO: K092232 (SPECIAL)

TERUMO PALL AL3X ARTERIAL FILTER
TERUMO CARDIOVASCULAR SYSTEMS CORP
510(k) NO: K083747 (TRADITIONAL)

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
MK BIO, INC
510(k) NO: K082977 (SPECIAL)

VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
HOLLISTER, INC.
510(k) NO: K090960 (TRADITIONAL)

TUTTNAUER ELARA-11“ PRE-VACUUM TABLETOP AUTOCLAVE
TUTTNAUER USA CO. LTD.
510(k) NO: K090783 (TRADITIONAL)

MERCURY CPAP
MERCURY MEDICAL
510(k) NO: K090710 (TRADITIONAL)

CABLE, TRANSDUCER, MODEL 2400GN
CONMED CORPORATION
510(k) NO: K083448 (TRADITIONAL)

LSVT C OR LSVT COMPANION, MODEL V.1
LSVT GLOBAL, LLC
510(k) NO: K091682 (TRADITIONAL)

MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH
HANDPIECE HEADQUARTERS
510(k) NO: K092053 (TRADITIONAL)

MODIFICATION TO PROFLU+ ASSAY
PRODESSE, INC.
510(k) NO: K092500 (SPECIAL)

THERMAPULSE
PALOMAR MEDICAL PRODUCTS, INC.
510(k) NO: K092222 (SPECIAL)

ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) NO: K092201 (SPECIAL)

XTRACT SYRINGE KEYS
XTRACT SOLUTIONS, LLC
510(k) NO: K091200 (TRADITIONAL)

TANTALUM BEAD SET, MODEL P003175
HALIFAX BIOMEDICAL, INC.
510(k) NO: K090581 (TRADITIONAL)

OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
PROTEC GMBH & CO. KG
510(k) NO: K091628 (TRADITIONAL)

FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
CAS MEDICAL SYSTEMS, INC.
510(k) NO: K091452 (TRADITIONAL)

CARE PAL, MODEL CPW-10X
DIGIO2 INTERNATIONAL CO., LTD
510(k) NO: K091430 (TRADITIONAL)

CLEAN PEAK FLOW METER
VIASYS HEALTHCARE GMBH
510(k) NO: K091412 (SPECIAL)

MYOSURE ROD LENS HYSTEROSCOPE
INTERLACE MEDICAL, INC.
510(k) NO: K091465 (TRADITIONAL)

AMSURE PVC INTERMITTENT CATHETER
AMSINO INTERNATIONAL, INC.
510(k) NO: K091306 (SPECIAL)

SKINTACT AND VARIOUS OTHER TRADENAMES
LEONHARD LANG GMBH
510(k) NO: K092291 (SPECIAL)

GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
GE MEDICAL SYSTEMS ISRAEL, ULTRASO
510(k) NO: K092140 (SPECIAL)

1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
INVIVO
510(k) NO: K091902 (TRADITIONAL)

MERCURY VCO2
RESPIRONICS NOVAMETRIX, INC.
510(k) NO: K092217 (SPECIAL)

DIRECTVISION GUIDE SYSTEM
PERCUVISION LLC
510(k) NO: K091600 (TRADITIONAL)

SATURN ACTIVE LASER SYSTEM
RESEARCH INSTRUMENTS LTD.
510(k) NO: K083208(ABBREVIATED)

SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
CONTEC MEDICAL SYSTEM CO., LTD.
510(k) NO: K090936 (TRADITIONAL)

VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
TALLEY MEDICAL
510(k) NO: K090258 (TRADITIONAL)

HEAD FIXATION ARC AND TABLE BASE
SURGIVISION, INC.
510(k) NO: K091439 (TRADITIONAL)

BD VACYTAUBER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 36877
BECTON DICKINSON AND COMPANY (BD)
510(k) NO: K091292 (TRADITIONAL)

BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
TAIDOC TECHNOLOGY CORPORATION
510(k) NO: K091897 (SPECIAL)

PROFEMUR HIP SYSTEM MODULAR NECKS
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) NO: K091423 (TRADITIONAL)

SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
SYNTHES (USA)
510(k) NO: K091144 (TRADITIONAL)

CERNER FETALINK (VERSION 1.0)
CERNER CORP.
510(k) NO: K091251 (TRADITIONAL)

IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR
IMASIGHT INC
510(k) NO: K092307 (TRADITIONAL)

GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
GE HEALTHCARE
510(k) NO: K092004 (TRADITIONAL)

NORDICBRAINEX SOFTWARE, VERSION 1.0
NORDICIMAGINGLAB AS
510(k) NO: K092102 (TRADITIONAL)

CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
HEMCON MEDICAL TECHNOLOGIES, INC.
510(k) NO: K092357 (SPECIAL)

COMMANDER 111, MODEL CD300-CD399
CARDIOCOM LLC
510(k) NO: K091821 (SPECIAL)

ERBE HYBRID KNIFE
ERBE USA, INC.
510(k) NO: K083608 (TRADITIONAL)

EKG-PLUS II SOFTWARE
BIONET CO., LTD.
510(k) NO: K090895 (TRADITIONAL)

SIGN HIP CONSTRUCT (SHC), MODEL: 701
SURGICAL IMPLANT GENERATION NETWOR
510(k) NO: K083582 (TRADITIONAL)

INSUFLOW
LEXION MEDICAL, LLC.
510(k) NO: K090456 (TRADITIONAL)

ARTHROSCOPE
ORTHOPEDIC SCIENCES, INC
510(k) NO: K091398 (TRADITIONAL)

COLLASORB COLLAGEN WOUND DRESSING
HARTMANN-CONCO INC.
510(k) NO: K091338 (TRADITIONAL)

XPECT FLU A & B
THERMO FISHER SCIENTIFIC
510(k) NO: K092423 (SPECIAL)

CORE*IT DUAL
SPIDENT CO., LTD.
510(k) NO: K092572 (TRADITIONAL)

CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
BAYER HEALTHCARE
510(k) NO: K091820 (SPECIAL)

INSPIRA HD, MODEL: NL1000
NEUROLOGICA CORPORATION
510(k) NO: K090811(ABBREVIATED)

MINISILK FT
EL.EN. ELECTRONIC ENGINEERING SPA
510(k) NO: K082040 (TRADITIONAL)

ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
BECKMAN COULTER, INC.
510(k) NO: K083867 (TRADITIONAL)

MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
MEDTRONIC PERFUSION SYSTEMS
510(k) NO: K090869 (TRADITIONAL)

WMT COMPOSITE DBM
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) NO: K083270 (TRADITIONAL)

SEGUIN ANNULOPLASTY RING
ST. JUDE MEDICAL
510(k) NO: K092310 (SPECIAL)

DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
TOSHIBA AMERICA ELECTRONIC COMPONE
510(k) NO: K092537 (TRADITIONAL)

MAMMOSITE MULTI LUMEN
HOLOGIC, INC.
510(k) NO: K092405 (SPECIAL)

SYNGO.X
SIEMENS AG, MEDICAL SOLUTIONS
510(k) NO: K092519 (TRADITIONAL)

FOX SV PTA CATHETER
ABBOTT VASCULAR
510(k) NO: K092286 (SPECIAL)

AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY(MCT) SYSTEM
CORVENTIS, INC.
510(k) NO: K091971 (SPECIAL)

WAVEON WRX BONE FIXATION SYSTEM
SONOMA ORTHOPEDIC PRODUCTS, INC.
510(k) NO: K090304 (TRADITIONAL)

LAGIS ENDOSCOPIC INSTRUMENTS
LAGIS ENTERPRISES CO, LTD.
510(k) NO: K090309 (TRADITIONAL)

SINUS QUICK EB SYSTEM
NEOBIOTECH CO., LTD.
510(k) NO: K090377 (TRADITIONAL)

PRIMER PLUS
BISCO, INC.
510(k) NO: K091705 (TRADITIONAL)

VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
THE PROCTER & GAMBLE CO.
510(k) NO: K091419 (TRADITIONAL)

VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
MAQUET CARDIOVASCULAR, LLC
510(k) NO: K091733 (SPECIAL)

LEDA
QUANTEL DERMA GMBH
510(k) NO: K090762 (TRADITIONAL)

QUATTRO PORCELAIN SYSTEM
DENTSPLY INTERNATIONAL, INC.
510(k) NO: K091706 (TRADITIONAL)

ELVIS HSV ID AND D3 TYPING TEST SYSTEM
DIAGNOSTIC HYBRIDS, INC.
510(k) NO: K091753 (TRADITIONAL)

MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
DIAGNOSTIC HYBRIDS, INC.
510(k) NO: K092300 (SPECIAL)

PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
BEST MEDICAL CANADA LTD.
510(k) NO: K092285 (SPECIAL)

PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
ISORAY MEDICAL, INC.
510(k) NO: K092458 (SPECIAL)

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
VORTEX MEDICAL INC
510(k) NO: K092486 (TRADITIONAL)

CARESCAPE MONITOR B850
GE MEDICAL SYSTEMS INFORMATION TEC
510(k) NO: K092027 (TRADITIONAL)

ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
ARTHREX, INC.
510(k) NO: K091844 (SPECIAL)

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
VASCUTEK LTD.
510(k) NO: K091778 (TRADITIONAL)

GRINDGUARD
GRIND GUARD TECHNOLOGIES, LLC
510(k) NO: K082723 (TRADITIONAL)

VS-SENSE TEST
COMMON SENSE, LTD.
510(k) NO: K091287 (TRADITIONAL)

TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
RTI BIOLOGICS, INC.
510(k) NO: K091142 (SPECIAL)

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