FDA 510(k) clearances — page 946

176,637 clearances on record, most recent first.

Clearances — page 946

94,501–94,600 of 176,637

K972092 — NASAL AIRWAY SPLINTBoston Medical Products, Inc.·Product code LYA·1997-07-08
K972146 — QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLSConsolidated Technologies, Inc.·Product code LYR·1997-07-08
K972273 — TBDMegadyne Medical Products, Inc.·Product code GEI·1997-07-08
K961734 — CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGETerumo Medical Corp.·Product code DTZ·1997-07-07
K963249 — EPILIGHT HAIR REMOVAL SYSTEMEsc Medical Systems , Ltd.·Product code GEX·1997-07-07
K963848 — MANUAL RESUSCITATOROwens-Brigam Medical Co.·Product code BTM·1997-07-07
K970318 — OCULAR CONFORMERSouthwest Artificial Eyes, Inc.·Product code HQN·1997-07-07
K970319 — OCULAR CONFORMERXavier A. Guerra, Ocularist, Inc.·Product code HQN·1997-07-07
K970320 — SCLERAL SHELLXavier A. Guerra, Ocularist, Inc.·Product code HQT·1997-07-07
K970327 — SCLERAL SHELLSouthwest Artificial Eyes, Inc.·Product code HQT·1997-07-07
K970995 — CMS CRYOLITECryomedical Sciences, Inc.·Product code GEH·1997-07-07
K971060 — PRECINORM TDM CONTROLSBoehringer Mannheim Corp.·Product code DIF·1997-07-07
K971302 — ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADEEthicon Endo-Surgery, Inc.·Product code LFL·1997-07-07
K971349 — BIOSIGN STREP A - DIRECT STREP A ANTIGEN TESTPrinceton BioMeditech Corp.·Product code GTY·1997-07-07
K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCKM-Pact Worldwide Management Corp.·Product code GEC·1997-07-07
K972151 — DOYLE COMBO NASAL AIRWAY SPLINTBoston Medical Products, Inc.·Product code LYA·1997-07-07
K972287 — DADE TRU-LIQUID BILIRUBIN CONTROLDade Intl., Inc.·Product code JJX·1997-07-07
K961044 — NOVIGUARD QUICK DRYDr. Novis Smith & Co., Inc.·Product code LRJ·1997-07-03
K961465 — 2008H ON LINE CLEARANCE MONITORFresenius USA, Inc.·Product code KDI·1997-07-03
K962767 — MS401097-17,MS722-K,MS720,MS721,MS722Alexander Mfg. Co.·Product code HLJ·1997-07-03
K964172 — MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTLMedtronic Vascular·Product code GZB·1997-07-03
K964873 — SILKAIR LOW AIRLOSS THERAPYHill-Rom, Inc.·Product code IOQ·1997-07-03
K965110 — N-ASSAY TIA MULTI CRP CALIBRATOR SETCrestat Diagnostics, Inc.·Product code DCK·1997-07-03
K965179 — INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOONeo Imagery Technologies, Inc.·Product code LLZ·1997-07-03
K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMPAbbott Mfg., Inc.·Product code FRN·1997-07-03
K965245 — TBDUtah Medical Products, Inc.·Product code HGI·1997-07-03
K970073 — BIO-ESTHETIC INDIRECT ABUTMENTSteri-Oss, Inc.·Product code NHA·1997-07-03
K970191 — UNIJECT EXAMINATION GLOVESUniject Gloves , Ltd.·Product code LYY·1997-07-03
K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTIIntermedics Orthopedics·Product code LPH·1997-07-03
K970383 — SHARPS CONTAINERCustom Medical Plastics, Inc.·Product code FMI·1997-07-03
K970398 — SHARPS CONTAINERCustom Medical Plastics, Inc.·Product code FMI·1997-07-03
K970548 — ONE STEP MARIJUANA CARD TESTTeco Diagnostics·Product code LDJ·1997-07-03
K970579 — ONE STEP MORPHINE CARD TESTTeco Diagnostics·Product code DNK·1997-07-03
K971268 — BONE & MARROW CLLECTION SYSTEMBiomedical International Corp.·Product code GEY·1997-07-03
K971278 — PURE COMPANY FLUID DELIVERY SYSTEMPure Co.·Product code EIA·1997-07-03
K971279 — VERSION 4 OPERATING SYSTEM SOFTWAREHitachi Medical Systems America, Inc.·Product code LNH·1997-07-03
K971347 — MEDISURFInternational Regulatory Consultants·Product code LMD·1997-07-03
K971380 — MEDRAD FLEX INTERFACE DEVICEMedrad, Inc.·Product code LNH·1997-07-03
K971448 — CORDIS OPTA LP PTA BALLOON CATHETERCordis Corp.·Product code LIT·1997-07-03
K971489 — RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4Philips Medical Systems North America, Inc.·Product code IZI·1997-07-03
K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONResound Corp.·Product code ESD·1997-07-03
K971631 — CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1997-07-03
K971633 — PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1997-07-03
K971635 — AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1997-07-03
K971666 — SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVESSj Medical Products (M) Sdn Bhd·Product code LZA·1997-07-03
K971699 — ARGOSY DYNAMEQArgosy Electronics·Product code ESD·1997-07-03
K971809 — ISOLATEIrvine Scientific Sales Co., Inc.·Product code MQL·1997-07-03
K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.·Product code LDR·1997-07-03
K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobind·Product code JNL·1997-07-03
K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAMonobind·Product code DDC·1997-07-03
K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.·Product code LDR·1997-07-03
K971866 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010Alexander Mfg. Co.·Product code FLL·1997-07-03
K971873 — LEVO ACTIVE-EASY LAELevo USA·Product code IPL·1997-07-03
K972019 — PEFECT SHOTInternational Imaging Electronics·Product code EIA·1997-07-03
K972036 — STEALTHThe Buzzz Corp.·Product code INI·1997-07-03
K972037 — PROWLERThe Buzzz Corp.·Product code INI·1997-07-03
K972038 — INTRUDERThe Buzzz Corp.·Product code INI·1997-07-03
K972060 — NASAL SEPTAL BUTTONBoston Medical Products, Inc.·Product code LFB·1997-07-03
K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82Pharmacia, Inc.·Product code DHB·1997-07-03
K972082 — CUSTOM NASAL SPLINTBoston Medical Products, Inc.·Product code LYA·1997-07-03
K972084 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212Alexander Mfg. Co.·Product code FLN·1997-07-03
K972089 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224Alexander Mfg. Co.·Product code MRZ·1997-07-03
K963190 — QA-40M DEFIBRILLATOR TESTERMetron U.S., Inc.·Product code DRL·1997-07-01
K964874 — HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, Inc.·Product code GQN·1997-07-01
K965236 — SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)Datascope Corp.·Product code DSP·1997-07-01
K970338 — TWEEZER-TYPE EPILATORIgia Direct, Inc.·Product code KCX·1997-07-01
K970481 — V2Survivalink Corp.·Product code LDD·1997-07-01
K970484 — ACCU-PREPBisco, Inc.·Product code KOJ·1997-07-01
K970657 — LMI THROMBECTOMY CATHETERLucas Medical, Inc.·Product code DXE·1997-07-01
K971101 — HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, Inc.·Product code GQN·1997-07-01
K971254 — TRANSEND EX PLATINUM GUIDEWIREBoston Scientific Corp·Product code DQX·1997-07-01
K971328 — OLYMPUS CD-6C-1 COAGULATION ELECTRODEOlympus America, Inc.·Product code FFE·1997-07-01
K971384 — (BRAND NAME)Long IN Time Ent. Co., Ltd.·Product code HQY·1997-07-01
K971462 — SUNGLASSESD.G. Prove Co.·Product code HQY·1997-07-01
K971472 — SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRATechnical Products, Inc.·Product code FTL·1997-07-01
K971536 — RESTRAINTS (VESTS AND JACKETS)E.M. Adams Co., Inc.·Product code FMQ·1997-07-01
K971861 — ULTRASONIC HAND INSTRUMENTSUnited States Surgical, A Division of Tyco Healthc·Product code LFL·1997-07-01
K963578 — PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)Intl. Products, Inc.·Product code DPS·1997-06-30
K964593 — DIASCOPE TRAVELLER PLUS (4053)S & W Medico Teknik A/S·Product code DSI·1997-06-30
K965147 — BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESISBoston Scientific Corp·Product code FGE·1997-06-30
K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.·Product code JQW·1997-06-30
K971250 — LASERSCOPE MICROBEAM IV MICROMANIPULATORLaserscope·Product code GEX·1997-06-30
K971469 — COULTER ACT TRON CELL CONTROLCoulter Corp.·Product code JPK·1997-06-30
K971527 — INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEMEmpi·Product code KPI·1997-06-30
K971578 — ENDOSSEOUS DENTAL IMPLANTStraumann USA·Product code DZE·1997-06-30
K971583 — MEDPOR OCULAR SCREW AND ACCEOSSORIESPorex Technologies Corp.·Product code MQU·1997-06-30
K971694 — ETEST FOR CEFTAZIDIMEAb Biodisk·Product code JWY·1997-06-30
K971750 — WELCH ALLYN PHACO ILLUMINATORWelch Allyn, Inc.·Product code HQC·1997-06-30
K971927 — HI DENSE TCShofu Dental Corp.·Product code EMA·1997-06-30
K972234 — RCT GEL ROOT CANAL THERAPY GELDentsply Intl.·Product code EIC·1997-06-30
K963160 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICEOlympus America, Inc.·Product code PKL·1997-06-27
K964131 — ENDOSCOPEAkos Biomedical, Inc.·Product code FAM·1997-06-27
K965002 — ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL ANDEncore Orthopedics, Inc.·Product code LZO·1997-06-27
K970720 — ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLEREthicon Endo-Surgery, Inc.·Product code OCW·1997-06-27
K970977 — LATEX EXAMINATION GLOVES, POWDER FREEArista Medi Prima·Product code LYY·1997-06-27
K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.·Product code KHO·1997-06-27
K971121 — ENCORE BONDCentrix, Inc.·Product code KLE·1997-06-27
K971123 — STONE EXTRACTORPhx Technologies Corp.·Product code OCZ·1997-06-27
K971130 — DEFEND FLUID RESISTANT PLEATED MASKCarl Parker Associates, Inc.·Product code FXX·1997-06-27
K971178 — RAND SURGICAL SPONGETrans Aire·Product code EFQ·1997-06-27

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