FDA 510(k) clearances — page 437

176,542 clearances on record, most recent first.

Clearances — page 437

43,601–43,700 of 176,542

K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing Corp·Product code HRY·2012-10-22
K122382 — DYNASTY BIOFOAM SHELLWrightmedicaltechnologyinc·Product code MBL·2012-10-22
K122482 — TRANSTEK WRIST BLOOD PRESSURE MONITORZhongshan Transtek Electronics Co., Ltd.·Product code DXN·2012-10-22
K122898 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNSurgical Specialties Corp. Dba Angiotech·Product code GAM·2012-10-22
K122984 — ATLAS GOLD PTA DILATATION CATHETERC.R. Bard, Inc.·Product code LIT·2012-10-22
K123019 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERSZimmer, Inc.·Product code LPH·2012-10-22
K112605 — SYSMEX XN-SERIESSysmex America, Inc.·Product code GKZ·2012-10-19
K113219 — ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.·Product code HSB·2012-10-19
K113867 — LACRICATH LACRIMAL DUCT CATHETERQuest Medical, Inc.·Product code OKS·2012-10-19
K120340 — VENUS FACET SCREW SYSTEMApollo Spine, Inc.·Product code MRW·2012-10-19
K120742 — XN CHECKStreck·Product code JPK·2012-10-19
K120744 — XN CHECK BFStreck·Product code JPK·2012-10-19
K120745 — XN CALStreck·Product code KRX·2012-10-19
K121484 — 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER3M Company·Product code FRC·2012-10-19
K121709 — ZFX DENTAL CAD SYSTEMZimmer Dental, Inc.·Product code NHA·2012-10-19
K121845 — SDX SYSTEMDyn'R Sas·Product code IYE·2012-10-19
K121876 — VERTECEM II CEMENT KITAap Biomaterials GmbH·Product code NDN·2012-10-19
K121931 — NONDISPOSABLE STIMULATING INSTRUMENTSNeurovision Medical Products, Inc.·Product code ETN·2012-10-19
K121962 — PRACTICAL COMPRESSION DEVICE (PCD) 901A&901BMego Afek AC , Ltd.·Product code JOW·2012-10-19
K121980 — ZIRPRIMEKuraray Noritake Dental, Inc.·Product code EIH·2012-10-19
K122170 — SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·Product code HSB·2012-10-19
K122173 — DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCCRayence Co., Ltd.·Product code MQB·2012-10-19
K122911 — VERSAFITCUP CC TRIO EXTENSIONMedacta International·Product code LZO·2012-10-19
K122913 — AFFINITY FUSION RECIRCULATION LINE MODEL RCL841Medtronic, Inc.·Product code DWF·2012-10-19
K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMMedrad, Inc.·Product code MCW·2012-10-19
DEN090012 — VIRULITE COLD SORE MACHINEVirulite, LLC·Product code OKJ·2012-10-18
K113469 — NIPRO HUBER INFUSION, EXCEL HUBER NEEDLENipro Medical Corporation·Product code FMI·2012-10-18
K113471 — NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SETNipro Medical Corporation·Product code FPA·2012-10-18
K120053 — IPS E.MAX PRESS - ABUTMENT SOLUTIONSIvoclar Vivadent, AG·Product code NHA·2012-10-18
K120420 — STERILE BLUNT FOR SINGLE USEShanghai Double Dove Industrial Co., Ltd.·Product code FMI·2012-10-18
K121741 — 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)4-Web, Inc.·Product code ODP·2012-10-18
K121849 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEECare Fusion·Product code DWM·2012-10-18
K121861 — SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & NSmith & Nephew, Inc.·Product code GAT·2012-10-18
K121881 — DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.·Product code HGI·2012-10-18
K122499 — AIRCAST VENAFLOW ELITE SYSTEMDjo, LLC·Product code JOW·2012-10-18
K122882 — NMI HPICC IIINavilyst Medical, Inc.·Product code LJS·2012-10-18
K122896 — COUGAR LS 15 LATERAL CAGE SYSTEMMedos International SARL·Product code MAX·2012-10-18
K113470 — NIPRO SAFE TOUCH HUBER INFUSION SETNipro Medical Corporation·Product code FPA·2012-10-17
K113706 — ENDOWRIST STAPLER SYSTEMIntuitive Surgical, Inc.·Product code NAY·2012-10-17
K120641 — GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGEGlobal Medi Products·Product code MEG·2012-10-17
K120947 — THS INSTRUMENT TRAYHologic, Inc.·Product code KCT·2012-10-17
K121344 — NU SLEEPRh Associates, LLC·Product code LRK·2012-10-17
K121581 — BOX PEEK VBR SYSTEM,Innovasis, Inc.·Product code MAX·2012-10-17
K122085 — STINGRAY CERVICAL CAGEOmni Surgical, LP Dba Spine360·Product code ODP·2012-10-17
K122131 — POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)Matang Mfg. Sdn. Bhd.·Product code LZA·2012-10-17
K122149 — QBTESQbtech AB·Product code LQD·2012-10-17
K122838 — LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEKBio-Rad Laboratories·Product code JJY·2012-10-17
K122844 — INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIRSorin Group Italia S.R.L.·Product code DTZ·2012-10-17
K122856 — CHARTER GUIDEWIREBrivant, Ltd.·Product code DQX·2012-10-17
K112217 — ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZERPolichem S.A·Product code NUC·2012-10-16
K120192 — DISPOSABLE SURGICAL GOWNSWeihai Hongyu Nonwoven Fabric Products Co., Ltd.·Product code FYA·2012-10-16
K121564 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0006Olympus Medical Systems Corp.·Product code IYN·2012-10-16
K121805 — AMS LARGE PORE POLYPROPHLENE MESHAmerican Medical Systems·Product code OTO·2012-10-16
K121992 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORXinwei (Shandong) Plastic and Rubber Products Co.,·Product code LZA·2012-10-16
K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERSSmith & Nephew, Inc.·Product code KWZ·2012-10-16
K122332 — TOWERLOX PEDICLE SCREW SYSTEMCaptiva Spine·Product code MNI·2012-10-16
K122465 — MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINKIndustrial Clothings, Ltd.·Product code LZA·2012-10-16
K123066 — ACCUMESH DEPLOYMENT SYSTEMCovidien, LLC·Product code ORQ·2012-10-16
K112087 — TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLSAdvanced Sterilization Products·Product code KCT·2012-10-15
K120889 — AESKUSLIDES ANA HEP-2Aesku Diagnostics·Product code DHN·2012-10-15
K121272 — PROTECH DENTAkervall Technologies, Inc.·Product code OBR·2012-10-15
K121483 — REUSABLE CUTANEOUS ELECTRODEAmpcare, LLC·Product code GXY·2012-10-15
K121627 — SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEMSmith & Nephew, Inc.·Product code MEH·2012-10-15
K121697 — FINGERTIP PULSE OXIMETERAndon Health Co, Ltd.·Product code DQA·2012-10-15
K121721 — LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)Abbott Medical Optics, Inc.·Product code HQC·2012-10-15
K122331 — CAVITY VARNISHDentsply International, Inc.·Product code LBH·2012-10-15
K122348 — QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOWRecherches Techniques Dentaires (R.T.D.)·Product code EBI·2012-10-15
K122497 — ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MMMedical Design, LLC·Product code KWQ·2012-10-15
K122547 — GRAM POSTITVE CLINDAMYCINbioMerieux, Inc.·Product code LON·2012-10-15
K122837 — AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.·Product code KZH·2012-10-15
K111981 — TREGOR DUAL MOBILITY ACETABULAR SYSTEMAston Medical·Product code LZO·2012-10-12
K120199 — GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRYBeckman Coulter, Inc.·Product code LCP·2012-10-12
K120595 — UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.·Product code LWJ·2012-10-12
K120652 — RAPICIDE OPA-28 TEST STRIPSerim Research Corp.·Product code JOJ·2012-10-12
K120831 — ANCHORSURENeomedic International S.L.·Product code PBQ·2012-10-12
K121002 — ETEST CEFTAROLINEbioMerieux, Inc.·Product code JWY·2012-10-12
K121317 — COCHLEAR BAHA IMPLANT SYSTEMCochlear Americas·Product code MAH·2012-10-12
K121598 — ME HAIR2GOSyneron Medical, Ltd.·Product code ONF·2012-10-12
K121624 — BIOMET MICROFIXATION NEURO PLATING SYSTEMBiomet Microfixation·Product code GWO·2012-10-12
K121651 — ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEMWrightmedicaltechnologyinc·Product code HRS·2012-10-12
K121688 — MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEMPrismatik Dentalcraft, Inc.·Product code NHA·2012-10-12
K122074 — IFUSE IMPLANT SYSTEMSI-BONE, Inc.·Product code OUR·2012-10-12
K122293 — PIONEER STERNAL CABLE PLATE SYSTEMPioneer Surgical Technology, Inc.·Product code HRS·2012-10-12
K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.·Product code JIX·2012-10-12
K122445 — AESPIRE 7900, AESPIRE VIEWDatex-Ohmeda·Product code BSZ·2012-10-12
K122574 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6Edan Instruments, Inc.·Product code IYO·2012-10-12
K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.·Product code DTL·2012-10-12
K121083 — TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINALoma Vista Medical·Product code OZT·2012-10-11
K121379 — PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORYAiron Corporation·Product code CBK·2012-10-11
K121543 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMSZimmer, Inc.·Product code KWT·2012-10-11
K121591 — FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)Tekmedic (M) Sdn Bhd·Product code LYY·2012-10-11
K121679 — ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics·Product code NBW·2012-10-11
K121696 — WIRELESS THERMOMETERRaling Medical Company·Product code FLL·2012-10-11
K121722 — ESA620 ELECTRICAL SAFETY ANALYZERFluke Biomedical·Product code DRT·2012-10-11
K121796 — WECK REUSABLE OBTURATORTeleflexmedical, Inc.·Product code GCJ·2012-10-11
K121883 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITKci USA, Inc. (Kinetic Concepts, Inc.)·Product code OMP·2012-10-11
K122168 — VISUALIF CHALLENGING ACCESS PLATESpine Smith Partners L.P.·Product code OVD·2012-10-11
K122178 — FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1Ostial Corporation·Product code LOX·2012-10-11
K122233 — CAPSURE(R) PS SYSTEMSpine Wave, Inc.·Product code MNI·2012-10-11
K122463 — APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT WCayenne Medical, Inc.·Product code MBI·2012-10-11

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