ONE PERSONAL LUBRICANT (WATER BASED)
ONE
510(k) NO: K110691(ABBREVIATED)

QUICKSCREEN COCAINE 150 SCREENING TEST
PHAMATECH INC.
510(k) NO: K103295(TRADITIONAL)

BIPAP A 30 VENTILATORY SUPPORT SYSTEM
RESPIRONICS, INC.
510(k) NO: K113053(ABBREVIATED)

PASS LP SPINAL
MEDICREA INTERNATIONAL
510(k) NO: K112736(TRADITIONAL)

KLASSIC KNEE SYSTEM
TOTAL JOINT ORTHOPEDICS, INC.
510(k) NO: K112906(TRADITIONAL)

PATIENT MONITOR
EDAN INSTRUMENTS, INC.
510(k) NO: K113623(TRADITIONAL)

GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
GOLD STANDARD DIAGNOSTICS
510(k) NO: K110899(TRADITIONAL)

SPSMEDICAL SPORVIEW STEAM BI
SPS MEDICAL SUPPLY CORP.
510(k) NO: K111515(TRADITIONAL)

SYNTHES USS CONNECTORS
SYNTHES SPINE
510(k) NO: K113149(TRADITIONAL)

SAVANNAH TECHNOLOGIES SPINAL SYSTEM
SAVANNAH TECHNOLOGIES LLC
510(k) NO: K113755(TRADITIONAL)

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
EVERYWAY MEDICAL INSTRUMENTS CO.,
510(k) NO: K112074(TRADITIONAL)

BRUNO ELAN STAIRWAY ELEVATOR
BRUNO INDEPENDENT LIVING AIDS, INC
510(k) NO: K113308(SPECIAL)

HAPTITE COATING IMPLANT SYSTEM
DENTIS CO., LTD.
510(k) NO: K111364(TRADITIONAL)

FREEMIE (R)
DAO HEALTH
510(k) NO: K111411(TRADITIONAL)

CONNEXALL SUITE OF SOFTWARE PRODUCTS
CONNEXALL USA, INC.
510(k) NO: K112650(TRADITIONAL)

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
ANGIOTECH
510(k) NO: K113744(TRADITIONAL)

RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
GREATBATCH MEDICAL
510(k) NO: K110051(TRADITIONAL)

MINI-MEDIC
ATHENA GTX
510(k) NO: K113165(TRADITIONAL)

NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
HARTALEGA SND. BHD.
510(k) NO: K112976(TRADITIONAL)

HERO GRAFT
HEMOSPHERE INC
510(k) NO: K120006(SPECIAL)

FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
FRESENIUS MEDICAL CARE, NORTH AMER
510(k) NO: K120017(SPECIAL)

APC FLASH-FREE ADHESIVE
3M UNITEK CORPORATION
510(k) NO: K113197(TRADITIONAL)

CMAP PRO
MEDICAL TECHNOLOGIES, INC.
510(k) NO: K113074(TRADITIONAL)

IDS-ISYS INTACT PTH
IMMUNODIAGNOSTIC SYSTEMS LTD.
510(k) NO: K103325(TRADITIONAL)

BLUE PAPOOSE MODEL SBL60
PHYSICIAN ENGINEERED PRODUCTS, INC
510(k) NO: K110550(TRADITIONAL)

AVEX CX, AND AVEX CXI CERAMIC BRACKETS
OPAL ORTHODONTICS BY ULTRADENT PRO
510(k) NO: K113334(TRADITIONAL)

CONTOUR HEALER
CONTOUR HEALER, LLC
510(k) NO: K112099(TRADITIONAL)

CONSERVE THIN SHELL
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) NO: K113322(SPECIAL)

CORAL SPINAL SYSTEM
THEKEN SPINE, LLC
510(k) NO: K120047(SPECIAL)

MANTARAY CATHETER
BRIDGEPOINT MEDICAL
510(k) NO: K120129(SPECIAL)

CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
CHISON MEDICAL IMAGING CO., LTD.
510(k) NO: K113359(TRADITIONAL)

PIEZOTOME SOLO
SATELEC - ACTEON, INC.
510(k) NO: K112188(TRADITIONAL)

PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
PLAYTEX MANUFACTURING INC.
510(k) NO: K111684(TRADITIONAL)

TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
TERATECH CORP.
510(k) NO: K112953(TRADITIONAL)

S-MINI IMPLANT SYSTEM
NEOBIOTECH CO., LTD.
510(k) NO: K112540(TRADITIONAL)

CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
CONFORMIS, INC.
510(k) NO: K120068(TRADITIONAL)

REST ASSURED GENERATION III DENTAL PROTECTOR
RANIR LLC
510(k) NO: K120103(SPECIAL)

METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
SOLANA SURGICAL LLC
510(k) NO: K113752(TRADITIONAL)

HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
SOLANA SURGICAL LLC
510(k) NO: K120029(TRADITIONAL)

AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
AESCULAP, INC.
510(k) NO: K111959(TRADITIONAL)

NAVIAID ICVI-F,S,B,R DEVICE
SMART MEDICAL SYSTEMS, LTD.
510(k) NO: K112106(TRADITIONAL)

POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
MAXTER GLOVE MANUFACTURING SDN BHD
510(k) NO: K113100(TRADITIONAL)

VASCULAR SONO
PAJUNK GMBH MEDIZINTECHNOLOGIE
510(k) NO: K113196(TRADITIONAL)

ARTUS INFL A/B RG RT-PCR KIT
QIAGEN, GMBH
510(k) NO: K113323(TRADITIONAL)

PATIENT MONITOR
EDAN INSTRUMENTS, INC.
510(k) NO: K113653(TRADITIONAL)

ZIO PATCH
IRHYTHM TECHNOLOGIES, INC.
510(k) NO: K113862(SPECIAL)

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
ARTHROSURFACE, INC.
510(k) NO: K113762(TRADITIONAL)

PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK USA
510(k) NO: K113642(TRADITIONAL)

ROTOR-GENE Q MDX
QIAGEN, GMBH
510(k) NO: K113319(TRADITIONAL)

FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION
510(k) NO: K111890(TRADITIONAL)

CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS
CORIN U.S.A.
510(k) NO: K111481(TRADITIONAL)

PATHWAY AVID
CUSTOM SPINE, INC.
510(k) NO: K111726(TRADITIONAL)

AQUILEX FLUID CONTROL SYSTEM H112
W.O.M. WORLD OF MEDICINE AG
510(k) NO: K112642(TRADITIONAL)

ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
ASAHI INTECC CO., LTD.
510(k) NO: K113716(TRADITIONAL)

CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
SKELETAL KINETICS, LLC
510(k) NO: K112383(TRADITIONAL)

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT
CSA MEDICAL, INC.
510(k) NO: K113021(TRADITIONAL)

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
SAFE SECURE PACKAGING CO., LTD 510(k) NO: K112591(TRADITIONAL)

ORTHO-1(NOT FINALIZED)
BISCO, INC.
510(k) NO: K113401(TRADITIONAL)

TLINK DATA MANAGEMENT SYSTEM (DMS)
TERUMO CARDIOVASCULAR SYSTEMS CORP
510(k) NO: K113214(TRADITIONAL)

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
ORTHO SOLUTIONS LIMITED
510(k) NO: K111678(TRADITIONAL)

MEDICAL IMAGE PROCESSING UNIT
HUMANRAY CO,LTD
510(k) NO: K113360(SPECIAL)

PROPHY-MATE NEO
NAKANISHI, INC.
510(k) NO: K112673(TRADITIONAL)

Z FLEX-270TM STEERABLE SHEATH
GREATBATCH MEDICAL
510(k) NO: K112541(TRADITIONAL)

JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
INTEGRA LIFESCIENCES CORPORATION
510(k) NO: K103726(TRADITIONAL)

WINGMAN EXTENDABLE TIP SUPPORT CATHETER
REFLOW MEDICAL
510(k) NO: K120178(SPECIAL)

SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
SYNTHES USA
510(k) NO: K120083(TRADITIONAL)

ORTHOSLENDERIZER
ORTHOMATICS, INC.
510(k) NO: K111249(TRADITIONAL)

CLEARFLASH AC2100 COSMETIC SYSTEM
CLEARFLASH TECHNOLOGIES, INC.
510(k) NO: K111937(TRADITIONAL)

DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
DELBIO INCORPORATION
510(k) NO: K113343(SPECIAL)

VERACIA SA
SHOFU DENTAL CORPORATION
510(k) NO: K113426(TRADITIONAL)

DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
MEDOS INTERNATIONAL SARL
510(k) NO: K113396(TRADITIONAL)

IM BAND
SYNEXMED (SHENZHEN) COMPANY LIMITE
510(k) NO: K113600(TRADITIONAL)

YOMURA SAFETY I.V. CATHETER
YOMURA TECHNOLOGIES INC.
510(k) NO: K112542(TRADITIONAL)

EPLGRAY
DOSLSOFT SA
510(k) NO: K112723(TRADITIONAL)

PUREIMAGE ULTRASOUND TRANSMISSION GEL
MEDLINE
510(k) NO: K120156(TRADITIONAL)

FLEXI-Q DV AND DVR AUTO-INJECTORS
ELCAM MEDICAL A.C.A.L.
510(k) NO: K111467(TRADITIONAL)

HPR EMOLLIENT FOAM
PRUGEN IP HOLDINGS, INC
510(k) NO: K113772(TRADITIONAL)

HPR PLUS EMOLLIENT FOAM
PRUGEN IP HOLDINGS, INC
510(k) NO: K113774(TRADITIONAL)

DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
DYNATRONICS CORP.
510(k) NO: K113250(TRADITIONAL)

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
SHANGHAI 3F ELECTRONICS CO LTD
510(k) NO: K113183(ABBREVIATED)

HAMILTON-TC1
HAMILTON MEDICAL AG
510(k) NO: K112006(TRADITIONAL)

INTEGRA WOUND MATRIX (THIN)
INTEGRA LIFESCIENCES CORPORATION
510(k) NO: K113104(TRADITIONAL)

CD HORIZON VOYAGER SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK
510(k) NO: K113529(TRADITIONAL)

AFX INTRODUCER SYSTEM
ENDOLOGIX, INC.
510(k) NO: K120212(SPECIAL)

STIMULATION/DISSECTION INSTRUMENTS
NUVASIVE, INCORPORATED
510(k) NO: K112709(TRADITIONAL)

PILLAR PALATAL IMPLANT SYSTEM
MEDTRONIC XOMED, INC.
510(k) NO: K110623(TRADITIONAL)

EXTRICARE
DEVON MEDICAL PRODUCTS, INC.
510(k) NO: K110078(TRADITIONAL)

MESO WOUND MATRIX
KENSEY NASH CORPORATION
510(k) NO: K112888(TRADITIONAL)

EIGR SURGICAL ILLUMINATION SYSTEM
INVUITY, INC.
510(k) NO: K113697(SPECIAL)

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
SPINE VIEW, INC.
510(k) NO: K113362(SPECIAL)

KINGYIELD WRIST BLOOD PRESSURE MONITOR
SHENZHEN KINGYIELD TECHNOLOGY CO.,
510(k) NO: K112042(TRADITIONAL)

AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
BESTGEN BIOTECH CORP.
510(k) NO: K103044(TRADITIONAL)

SENSE MSK S 8CH 1.5T
INVIVO CORPORATION
510(k) NO: K120122(SPECIAL)

VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
BIOMERIEUX, INC.
510(k) NO: K113305(TRADITIONAL)

REGIUS SIGMA2
KONICA MINOLTA MEDICAL & GRAPHIC,
510(k) NO: K120131(SPECIAL)

L-SER KO LAMP
YA-MAN LTD
510(k) NO: K112016(TRADITIONAL)

AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
PANASONIC HEALTHCARE CO., LTD.
510(k) NO: K113612(TRADITIONAL)

NOTOUCH BREASTSCAN
UE LIFESCIENCES, INC.
510(k) NO: K113259(TRADITIONAL)

SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
SALTER LABS, ARVIN FACILITY
510(k) NO: K113542(TRADITIONAL)

CRE DITATATION BALLON
BOSTON SCIENTIFIC CORPORATION
510(k) NO: K112994(TRADITIONAL)

AMID STAPLER
SAFESTICH MEDICAL, LLC
510(k) NO: K120268(SPECIAL)

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
DENTSPLY INTERNATIONAL, INC.
510(k) NO: K113406(TRADITIONAL)

BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, HANGZHOU BEVER MEDICAL DEVICES CO.
510(k) NO: K111405(TRADITIONAL)

COFLEX-F
PARADIGM SPINE, LLC
510(k) NO: K112595(TRADITIONAL)

POLYFUSE - NEUROBONE
ATPAC MEDICAL LLC
510(k) NO: K111018(TRADITIONAL)

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
COOK IRELAND LTD
510(k) NO: K113634(SPECIAL)

LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
MERIDIAN AG
510(k) NO: K113390(TRADITIONAL)

GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
GE MEDICAL SYSTEMS SCS
510(k) NO: K113403(TRADITIONAL)

SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
PHILIPS MEDICAL SYSTEMS
510(k) NO: K120132(SPECIAL)

VICTORY GUIDEWIRE (32 MODELS)
BRIVANT, LTD.
510(k) NO: K120137(SPECIAL)

CADENS (TM) COLON
DOG MICROSYSTEMS, INC.
510(k) NO: K111758(TRADITIONAL)

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
COLOPLAST A/S
510(k) NO: K113496(TRADITIONAL)

VITAL SIGNS MONITOR
EDAN INSTRUMENTS INC
510(k) NO: K120144(SPECIAL)

IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
IMMUNODIAGNOSTIC SYSTEMS LTD.
510(k) NO: K111938(ABBREVIATED)

DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
FULL SYNERGY MEDICAL PRODUCTS INC
510(k) NO: K113710(ABBREVIATED)

DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
FULL SYNERGY MEDICAL PRODUCTS INC
510(k) NO: K113722(TRADITIONAL)

OLYMPUS INSTRUMENT TRAY
OLYMPUS WINTER & IBE GMBH
510(k) NO: K110748(TRADITIONAL)

CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
NAKANISHI, INC.
510(k) NO: K110278(TRADITIONAL)

S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
HOWMEDICA OSTEONICS CORP.
510(k) NO: K113409(TRADITIONAL)

CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.
510(k) NO: K113378(TRADITIONAL)

TEPHAFLEX LIGHT MESH
TEPHA, INC.
510(k) NO: K113721(TRADITIONAL)

TEPHAFLEX MESH
TEPHA, INC.
510(k) NO: K113723(TRADITIONAL)

ELECTROPULSE-COSMETIC
PAIN RELIEF TECHNOLOGIES
510(k) NO: K113724(TRADITIONAL)

FOCUS SPINAL SYSTEM
L&K BIOMED CO., LTD
510(k) NO: K120140(SPECIAL)

EAUM TOTAL KNEE SYSTEM
CORENTEC CO., LTD
510(k) NO: K110404(TRADITIONAL)

3DI
SHINA SYSTEMS LTD.
510(k) NO: K113442(TRADITIONAL)

PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
PHILIPS MEDICAL SYSTEMS
510(k) NO: K110825(TRADITIONAL)

UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
IMPACT INSTRUMENTATION, INC.
510(k) NO: K111473(TRADITIONAL)

EVIS EXERA III VIDEO SYSTEM
OLYMPUS MEDICAL SYSTEMS CORPORATIO
510(k) NO: K112680(TRADITIONAL)

WAVES WATERS ADVANCED VIABILITY EVALUATION SYSTEM
WATERS MEDICAL SYSTEMS, LLC
510(k) NO: K111521(TRADITIONAL)

VISIA NEURO
MEVIS MEDICAL SOLUTIONS AG
510(k) NO: K113701(TRADITIONAL)

BD MAX GBS ASSAY, BD MAX INSTRUMENT
BECTON DICKINSON & CO.
510(k) NO: K111860(TRADITIONAL)

SURFACE BEACON TRANSPONDERS
CALYPSO MEDICAL TECHNOLOGIES INC
510(k) NO: K112841(TRADITIONAL)

COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
BIOMET, INC.
510(k) NO: K120121(SPECIAL)

PLEURX PLEURAL CATHETER SYSTEMS
CAREFUSION
510(k) NO: K112831(TRADITIONAL)

ICON (TM) MODULAR PEDICLE SCREW SYSTEM
ORTHOFIX, INC.
510(k) NO: K111448(TRADITIONAL)

STLASE
DENTAL PHOTONICS, INC
510(k) NO: K111689(TRADITIONAL)

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
MEDOS INTERNATIONAL SARL
510(k) NO: K113526(SPECIAL)

KOWA VX-20
KOWA CO. LTD.
510(k) NO: K112330(TRADITIONAL)

FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
ABBOTT LABORATORIES
510(k) NO: K111874(TRADITIONAL)

CS IMAGING
TROPHY
510(k) NO: K113419(TRADITIONAL)

CHROMOPHARE F 628 AND F 528
BERCHTOLD GMBH & CO. KG
510(k) NO: K120392(TRADITIONAL)

3B WILLOW
3B PRODUCTS, LLC
510(k) NO: K112271(TRADITIONAL)

ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
APOLLO SPINE
510(k) NO: K120143(SPECIAL)

I-PORT ADVANCE INJECTION PORT
UNOMEDICAL A/S
510(k) NO: K120337(ABBREVIATED)

ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
SPINEFRONTIER, INC.
510(k) NO: K113518(ABBREVIATED)

CLOSER TO NATURE ELECTRIC BREAST PUMP
MAYBORN GROUP LIMITED
510(k) NO: K113664(TRADITIONAL)

SIRONA DENTAL CAD/CAM SYSTEM
SIRONA DENTAL SYSTEMS GMBH
510(k) NO: K111421(TRADITIONAL)

TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
LUMINEX MOLECULAR DIAGNOSTICS, INC
510(k) NO: K112781(TRADITIONAL)

HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
ORTHOCON
510(k) NO: K113627(SPECIAL)

POWDERFREE POLYISOPRENE SURGICAL GLOVES
PT. MEDISAFE TECHNOLOGIES
510(k) NO: K112654(TRADITIONAL)

VALEO VT-601 SERIES IR THERMOMETER
VALEO CORP.
510(k) NO: K111463(TRADITIONAL)

ARTHREX KNOTLESS SUTURETAK ANCHOR
ARTHREX, INC.
510(k) NO: K120155(SPECIAL)

VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
GREINER BIO-ONE NORTH AMERICA, INC
510(k) NO: K113505(TRADITIONAL)

NANOBLUTM 500
DRAEGER MEDICAL SYSTEMS, INC.
510(k) NO: K113206(TRADITIONAL)

EQUIVITAL
HIDALGO LIMITED
510(k) NO: K113054(SPECIAL)

CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS HEALTHCARE
510(k) NO: K120321(TRADITIONAL)

VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
BIOMERIEUX, INC.
510(k) NO: K111976(TRADITIONAL)

TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
NT-TRADING GMBH AND CO KG
510(k) NO: K111935(TRADITIONAL)

GEODESIC EEG MOBILE 100 (GEM 100)
BOVARD CONSULTING LLC
510(k) NO: K112353(TRADITIONAL)

ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
ASCENDX SPINE, INC.
510(k) NO: K113452(TRADITIONAL)

AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
KENTEC MEDICAL, INC.
510(k) NO: K120272(TRADITIONAL)

ACE STAPLER AND CARTRIDGE
BAROSENSE, INC
510(k) NO: K120147(SPECIAL)

ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
ACUTE INNOVATIONS LLC
510(k) NO: K120163(SPECIAL)

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
CINCINNATI SUB-ZERO PRODUCTS, INC.
510(k) NO: K120081(TRADITIONAL)

WAGNER CONE PROSTHESIS SYSTEM
ZIMMER GMBH
510(k) NO: K113556(SPECIAL)

BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
WENZHOU BOKANG INSTRUMENT CO.,LTD
510(k) NO: K111141(ABBREVIATED)

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS CORPORATION
510(k) NO: K113520(SPECIAL)

SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
MATERIALISE DENTAL NV
510(k) NO: K112679(TRADITIONAL)

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
VENTANA MEDICAL SYSTEMS, INC.
510(k) NO: K111755(TRADITIONAL)

LEFORTE NEURO SYSTEM BONE PLATE
JEIL MEDICAL CORPORATION
510(k) NO: K112812(SPECIAL)

INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
INTEGRA BURLINGTON MA, INC.
510(k) NO: K113570(TRADITIONAL)

SMARTHEART
SHL TELEMEDICINE INTERNATIONAL LTD
510(k) NO: K113514(TRADITIONAL)

INCONTROL
INCONTROL MEDICAL, LLC
510(k) NO: K110179(TRADITIONAL)

RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS
BELLA ELEVATOR, LLC
510(k) NO: K113065(TRADITIONAL)

SPECTRA LASER SYSTEM
LUTRONIC CORPORATION
510(k) NO: K113588(TRADITIONAL)

BONETRAP
BERNI FARNS INCORPORATED
510(k) NO: K120189(TRADITIONAL)

ASPIRE MAX ASPIRATION CATHETER
CONTROL MEDICAL TECHNOLOGY, LLC
510(k) NO: K113757(TRADITIONAL)

INVENDO C20 COLONOSCOPY SYSTEM
INVENDO MEDICAL GBMH
510(k) NO: K100624(TRADITIONAL)

BLUESHINE'S GOLD SERIES
BLUESHINE SRL
510(k) NO: K110375(TRADITIONAL)

PILAIRO NASAL PILLOWS MASK
FISHER & PAYKEL HEALTHCARE LIMITED
510(k) NO: K120027(TRADITIONAL)

ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
NAKAMURA DENTAL HANDPIECE MFG. CO.
510(k) NO: K113222(TRADITIONAL)

KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
TORNIER
510(k) NO: K111970(TRADITIONAL)

UPSTREAM SUPPORT CATHETER
UPSTREAM PERIPHERAL TECHNOLOGIES
510(k) NO: K112886(TRADITIONAL)

COLLAGEN RIBBON
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) NO: K120019(TRADITIONAL)

FIXATE TISSUE BAND
ANULEX TECHNOLOGIES, INC
510(k) NO: K113805(TRADITIONAL)

KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10
KAT IMPLANTS, LLC
510(k) NO: K112758(TRADITIONAL)

PROULTRA PIEZO ULTRASONIC
SATELEC-ACTEON GROUP
510(k) NO: K113430(TRADITIONAL)

SUREFIRE GUIDE SHEATH
SUREFIRE MEDICAL, INC
510(k) NO: K113737(SPECIAL)

Q. FREEZE (MOTION VUE2)
GE MEDICAL SYSTEMS, LLC
510(k) NO: K113408(TRADITIONAL)

SOL-M EXCHANGEABLE NEEDLES
SOL-MILENNIUM MEDICAL, INC.
510(k) NO: K112777(TRADITIONAL)

SONY LMD-2451MT LCD MONITOR
SONY ELECTRONICS, INC.
510(k) NO: K113203(TRADITIONAL)

JETSTREAM NAVITUS L SYSTEM
PATHWAY MEDICAL TECHNOLOGIES, INC.
510(k) NO: K120242(SPECIAL)

SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS
LIMACORPORATE S.P.A.
510(k) NO: K113254(TRADITIONAL)

LINEAR HIP STEM, SIZE 5
ENCORE MEDICAL, L.P.
510(k) NO: K120241(SPECIAL)

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
WELLDOC, INC
510(k) NO: K120314(SPECIAL)

MEDIGUIDE TECHNOLOGY
ST. JUDE MEDICAL, MEDIGUIDE NAVIGA
510(k) NO: K120301(SPECIAL)

TRU LEGIONELLA
MERIDIAN BIOSCIENCE, INC.
510(k) NO: K113190(TRADITIONAL)

ENVOY DISTAL ACCESS GUIDING CATHETER
CODMAN & SHURTLEFF, INC.
510(k) NO: K120229(SPECIAL)

SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
SINTEA PLUSTEK, LLC
510(k) NO: K112861(SPECIAL)

SITESCRUB IPA DEVICE
CR BARD
510(k) NO: K112791(TRADITIONAL)

14 WIRE STANDARD, 14 WIRE LS
MICRO THERAPEUTICS, INC.
510(k) NO: K113454(TRADITIONAL)

Q50 PLUS STENT GRAFT BALLOON CATHETER
QXMEDICAL, LLC
510(k) NO: K120381(TRADITIONAL)

AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
SHANTOU WEALY MEDICAL INSTRUMENT C
510(k) NO: K113587(TRADITIONAL)

MASIMO SET REUSABLE OXIMETRY SENSORS
MASIMO CORPORATION
510(k) NO: K113596(SPECIAL)

BLOOD PRESSURE MONITOR
NIHON SEIMITSU SOKKI CO., LTD.
510(k) NO: K112690(TRADITIONAL)

BLOOD PRESSURE MONITOR
NIHON SEIMITSU SOKKI CO., LTD.
510(k) NO: K112691(TRADITIONAL)

CONNEX WORKSTATION
WELCH ALLYN, INC.
510(k) NO: K120343(SPECIAL)

RADIFORCE RX240
EIZO NANAO CORPORATION
510(k) NO: K113844(TRADITIONAL)

BARF BAND
DOODLEBUG PRODUCTS, LLC
510(k) NO: K110821(TRADITIONAL)

VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN
DEPUY MITEK, A JOHNSON & JOHNSON C
510(k) NO: K113545(TRADITIONAL)

CATALYST
C-RAD POSITIONING AB
510(k) NO: K113276(TRADITIONAL)

X-RAY VVA
MEDIS MEDICAL IMAGING SYSTEMS, B.V
510(k) NO: K112807(TRADITIONAL)

JOURNEY II DEEP DISHED ARTICULAR INSERTS
SMITH & NEPHEW, INC.
510(k) NO: K113482(TRADITIONAL)

WARP10,WARP75
QUANTUM DEVICES, INC.
510(k) NO: K113231(TRADITIONAL)

COMPRESSIBLE LIMB THERAPY SYSTEM
WONJINMULSAN CO., LTD.
510(k) NO: K113275(TRADITIONAL)

BIONIME DIABETES MANAGEMENT SYSTEM VI.0
BIONIME CORPORATION
510(k) NO: K113007(TRADITIONAL)

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
THE BINDING SITE
510(k) NO: K103824(TRADITIONAL)

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
TIANJIN EMPECS MEDICAL DEVICE CO.,
510(k) NO: K111456(TRADITIONAL)

TISSUE MARKER
FOCAL THERAPEUTICS
510(k) NO: K113202(TRADITIONAL)

VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
BIOMERIEUX, INC.
510(k) NO: K111893(TRADITIONAL)

TOSHIBA 1.5T CARDIAC COIL
QUALITY ELECTRODYNAMICS
510(k) NO: K120290(TRADITIONAL)

MOSAIQ ONCOLOGY INFORMATION SYSTEM
IMPAC MEDICAL SYSTEMS, INC.
510(k) NO: K120067(TRADITIONAL)

NEON SYSTEM
ULRICH GMBH & CO. KG
510(k) NO: K113346(TRADITIONAL)

MECTALIF TRANSFORAMINAL
MEDACTA INTERNATIONAL, SA
510(k) NO: K120024(SPECIAL)

E-PASS
SYNEXMED(SHENZHEN)COMPANY LIMITED
510(k) NO: K113148(TRADITIONAL)

APEX REVISION KNEE SYSTEMS
OMNI LIFE SCIENCE, INC.
510(k) NO: K112891(TRADITIONAL)

QUANTUM BARIATRIC 451
PRIDE MOBILITY PRODUCT CORPORRATIO
510(k) NO: K112815(SPECIAL)

SONO TAP, TUOHY SONO
PAJUNK GMBH
510(k) NO: K113207(TRADITIONAL)

DYNANAIL ANKLE ARTHRODESIS NAIL
MEDSHAPE, INC
510(k) NO: K113828(TRADITIONAL)

SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
SPINEOLOGY, INC.
510(k) NO: K120293(SPECIAL)

DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
COVIDIEN, FORMERLY US SURGICAL A D
510(k) NO: K120258(TRADITIONAL)

INOMAX DS(DELIVERY SYSTEMS
INO THERAPEUTICS LLC/DBA IKARIA
510(k) NO: K113272(SPECIAL)

CLEANE / CLEANE POP
MEDICON CO., LTD.
510(k) NO: K111341(TRADITIONAL)

7MM LCP ULNU OSTEOTOMY SYSTEM
SYNTHES (USA) PRODUCTS LLC
510(k) NO: K113364(TRADITIONAL)

HEALIX ADVANCE BR ANCHOR
DEPUY MITEK INC., JOHNSON AND JOHN
510(k) NO: K120078(TRADITIONAL)

VANGUARD COMPLETE KNEE SYSTEM
BIOMET MANUFACTURING CORP.
510(k) NO: K113550(TRADITIONAL)

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