FDA 510(k) clearances — page 995

176,637 clearances on record, most recent first.

Clearances — page 995

99,401–99,500 of 176,637

K961534 — SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)Sa Scientific, Inc.·Product code GNB·1996-05-20
K961535 — SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961538 — SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961539 — SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961540 — SAS SHIGELLA SONNEI GROUP D ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961541 — SAS SHIGELLA BOYDII TYPE 8 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961542 — SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961543 — SAS SHIGELLA BOYDII TYPE 9 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961546 — SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961547 — SAS SHIGELLA BOYDII TYPE 14 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961548 — SAS SHIGELLA BOYDII TYPE 15 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961549 — SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961551 — SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961553 — SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961554 — SAS SHIGELLA BOYDII TYPE 10 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961556 — SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961558 — SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K961559 — SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUMSa Scientific, Inc.·Product code GNB·1996-05-20
K941593 — DIAGNOSTIC ULTRASONIC TRANSDUCERToshiba America Medical Systems, In.C·Product code IYO·1996-05-17
K944497 — UNILECT, MONITAB AND BIOTRACE-HRMsb , Ltd.·Product code DRX·1996-05-17
K951951 — FOCUS MODEL 795 UNITEmpi·Product code GZJ·1996-05-17
K955146 — AXIOM-HVGAxiom Manufacturing·Product code IPF·1996-05-17
K955286 — EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)Johnson & Johnson Clinical Diagnostics, Inc.·Product code CGA·1996-05-17
K955291 — DUALSCREENMedtronic Vascular·Product code GZB·1996-05-17
K955800 — SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODECmc Sense-It, Inc.·Product code DRX·1996-05-17
K960641 — RECAP-1Medscience, Inc.·Product code FMI·1996-05-17
K960642 — NANCY NAILLandos, Inc.·Product code HTY·1996-05-17
K960663 — UNIVERSAL BITE BLOCKB&B Medical Technologies, Inc.·Product code JXL·1996-05-17
K960675 — WALKHALER PORTABLE COMPRESSOR MODEL 45F70Pari Holding Co.·Product code CAF·1996-05-17
K960776 — MICRO21 WITH RETICTriangle Biomedical Sciences, Inc.·Product code JOY·1996-05-17
K960807 — TEW CRANIAL/SPINAL RETRACTOR MODEL A1090Ohio Medical Instrument Co., Inc.·Product code GZT·1996-05-17
K960827 — QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)Becton Dickinson Diagnostic Instrument Systems·Product code GKZ·1996-05-17
K960887 — MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEDako Corp.·Product code GKZ·1996-05-17
K961157 — WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREWWhiteside Biomechanics, Inc.·Product code HWC·1996-05-17
K961200 — BOSWORTH LIQUID RESIN IIHarry J. Bosworth Co.·Product code EBI·1996-05-17
K961201 — BOSWORTH IMPRESSION MATERIAL IIHarry J. Bosworth Co.·Product code ELW·1996-05-17
K961622 — PHONAK PICONET2 P2 AZPhonak, Inc.·Product code ESD·1996-05-17
K961755 — CYTOQUANT CHLAMYDIA TRANSPORT MEDIUMProteins Intl., Inc.·Product code JSN·1996-05-17
K961756 — CYTOQUANT VIRAL TRANSPORT MEDIUMProteins Intl., Inc.·Product code JSN·1996-05-17
K941553 — MAGNES II BIOMAGNETOMETERBiomagnetic Technologies, Inc.·Product code OLX·1996-05-16
K944496 — BIOTRACE-N, NS, 410 AND RTMsb , Ltd.·Product code DRX·1996-05-16
K950335 — KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGYKARL STORZ Endoscopy-America, Inc.·Product code HET·1996-05-16
K953434 — MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)Midas Rex Pneumatic Tools, Inc.·Product code HBB·1996-05-16
K953559 — LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)Seidel Medizin GmbH·Product code BTO·1996-05-16
K954053 — BERLIN EXTERNAL FIXATOREncore Orthopedics, Inc.·Product code LXT·1996-05-16
K954389 — CONMED ECG/EKG ELECTRODESConmedcorp·Product code DRX·1996-05-16
K954419 — SPECTACLE FRAMES/SUNGLASSESAmi Fashion·Product code HQY·1996-05-16
K955304 — CRICKETMicrovena Corp.·Product code DQX·1996-05-16
K955777 — PMMA CLASICRand Scientific Corp.·Product code HPX·1996-05-16
K960821 — SLT FUMICH PROBE GUIDESurgical Laser Technologies, Inc.·Product code GEX·1996-05-16
K960954 — KETAC-MOLAR APLICAPEspe GmbH & Co. Kg.·Product code EMA·1996-05-16
K961057 — DURALASTIC SHEETING IIRand Scientific Corp.·Product code MIB·1996-05-16
K961067 — BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKETMedtrak Intl., Inc.·Product code MGQ·1996-05-16
K961087 — DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERSDebusk Knitting Mills, Div. Deroyal Industries·Product code GEI·1996-05-16
K961168 — VIEWPOINTPhilips Medical Systems (Cleveland), Inc.·Product code GAW·1996-05-16
K961224 — HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEMDavol Inc., Sub. C. R. Bard, Inc.·Product code GCJ·1996-05-16
K961286 — STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSESIntl. Optical Mfg. Co., Ltd.·Product code HQY·1996-05-16
K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORSSterilab, Inc.·Product code HNY·1996-05-16
K961746 — CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEYEurotrends Eyewear, Inc.·Product code HQY·1996-05-16
K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERMedi-Tech, Inc.·Product code KRA·1996-05-15
K954980 — PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIOHewlett-Packard Co.·Product code LOS·1996-05-15
K955356 — ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLDiagnostic Systems Laboratories, Inc.·Product code CGI·1996-05-15
K955533 — DIASTAT VASCULAR ACCESS GRAFTW. L. Gore & Associates, Inc.·Product code DYF·1996-05-15
K955585 — V2 INJECTION SITEB.Braun Medical, Inc.·Product code FPA·1996-05-15
K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.·Product code DWS·1996-05-15
K960058 — OXITEMP, 3301T SABci Intl., Inc.·Product code DQA·1996-05-15
K960277 — PROTECTIVE LATEX POWDERED GLOVESHighactive Sdn. Bhd.·Product code LYY·1996-05-15
K960713 — 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)Arrow Intl., Inc.·Product code DSP·1996-05-15
K960969 — GALVA 5-TZimmer Elektromedizin GmbH·Product code GZJ·1996-05-15
K961015 — SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIREScimed Life Systems, Inc.·Product code DQX·1996-05-15
K961195 — CHEM-CHEX STATStreck Laboratories, Inc.·Product code JJY·1996-05-15
K961196 — EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)Johnson & Johnson Clinical Diagnostics, Inc.·Product code CDN·1996-05-15
K961256 — SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENTBeckman Instruments, Inc.·Product code LEG·1996-05-15
K961273 — AED CALIBRATORSDiagnostic Reagents, Inc.·Product code DKB·1996-05-15
K961280 — SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10FScimed Life Systems, Inc.·Product code DQY·1996-05-15
K961327 — BEC NEEDLELESS INJECTION SITEBiological & Environmental Control Laboratories·Product code FPA·1996-05-15
K961349 — INJECTION GOLD PROBEBoston Scientific Corp·Product code KNS·1996-05-15
K961492 — HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010Davol Inc., Sub. C. R. Bard, Inc.·Product code GCJ·1996-05-15
K944867 — TOXOSTATBio-Whittaker, Inc., A Cambrex Co.·Product code LGD·1996-05-14
K945105 — POLY/PLATINUM WIRE PISTONMicromed Development Corp.·Product code ETB·1996-05-14
K950712 — PORTABLE ENDOSCOPY SYSTEMLaser-Optik-Systeme GmbH & Co. KG·Product code GCM·1996-05-14
K951877 — AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINEChimera Research & Chemical, Inc.·Product code KQO·1996-05-14
K953083 — HOSPITAL LAUNDRY SERVICES SURGICAL PACKSHospital Laundry Services·Product code LRO·1996-05-14
K954318 — ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAYAbbott Laboratories·Product code LFX·1996-05-14
K954325 — NEOLON NEOPRENE SURGICAL GLOVESMaxxim Medical·Product code KGO·1996-05-14
K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)International Biophysics Corp.·Product code DRY·1996-05-14
K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)International Biophysics Corp.·Product code DRY·1996-05-14
K955412 — A.S.D. SAFETY TROCARAmerican Surgical Devices·Product code HET·1996-05-14
K955583 — VIFSKonica Medical Corp.·Product code JAK·1996-05-14
K955659 — DRUGBOXC.F. Electronics, Inc.·Product code LGZ·1996-05-14
K960639 — ABUTMENT SELECTION KITNobelpharma USA, Inc.·Product code DZE·1996-05-14
K960768 — LASER FIBER DELIVERY/CLEANING CATHETERCook Urological, Inc.·Product code GEX·1996-05-14
K960787 — TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSBaxter Healthcare Corp·Product code LJH·1996-05-14
K960867 — FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532)B.V. Intl. S.A.·Product code GEX·1996-05-14
K961178 — KARL STORZ INTUBATION FIBERSCOPEKARL STORZ Endoscopy-America, Inc.·Product code EOQ·1996-05-14
K961670 — CLARITYSeig Technologies, Inc.·Product code ESD·1996-05-14
K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)Ortho Diagnostic Systems, Inc.·Product code GKZ·1996-05-13
K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)Ortho Diagnostic Systems, Inc.·Product code GKZ·1996-05-13
K950989 — CARDIOSMARTHellige GmbH·Product code DPS·1996-05-13
K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)Ortho Diagnostic Systems, Inc.·Product code GKZ·1996-05-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.