FDA 510(k) clearances — page 1071

176,637 clearances on record, most recent first.

Clearances — page 1071

107,001–107,100 of 176,637

K944213 — 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREWHowmedica Corp.·Product code HWC·1994-12-09
K944229 — OLYMPUS AMYLASE REAGENTOlympus America, Inc.·Product code JFJ·1994-12-09
K944460 — DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARDDatascope Corp.·Product code DSP·1994-12-09
K944490 — AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OY·Product code CGI·1994-12-09
K944703 — THYROXINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.·Product code KLI·1994-12-09
K944808 — IMX T3 ASSAYOrganon Teknika Corp.·Product code CDP·1994-12-09
K944934 — POLYURETHANE SOLUTION 29% W/WKnowell Therapeutic Technologies,Inc.·Product code LBH·1994-12-09
K944967 — TOMO-LINKGE Medical Systems·Product code IZF·1994-12-09
K945194 — ABUSCREEN ONLINE CONTROLSRoche Diagnostic Systems, Inc.·Product code DIF·1994-12-09
K945195 — ABUSCREEN ONLINE PROPOXPHENERoche Diagnostic Systems, Inc.·Product code JXN·1994-12-09
K945287 — INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICEHelix Medical, Inc.·Product code EWL·1994-12-09
K945315 — DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROLCasco Standards·Product code JJY·1994-12-09
K945353 — CLARIT(TM)Advanced Biomedical Methods, Inc.·Product code JKA·1994-12-09
K945483 — COMPASGeneral Electric Co.·Product code IZI·1994-12-09
K945507 — H 5100, H 5200, H 5300Rudolf Riester GmbH & Co. KG·Product code KZF·1994-12-09
K945573 — BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.·Product code KNW·1994-12-09
K930731 — SLIP-COAT STENTSCook Urological, Inc.·Product code FAD·1994-12-08
K935923 — PHILIPS ULTRASOUND P800 IMAGING SYSTEMHewlett-Packard Co.·Product code IYN·1994-12-08
K941128 — OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTSOsteonics Corp.·Product code JWH·1994-12-08
K941560 — IMMUNOCARD H. PYLORIMeridian Diagnostics, Inc.·Product code LYR·1994-12-08
K942082 — MODEL 6323 OXYGEN CONCENTRATORDynotec Corp.·Product code CAW·1994-12-08
K942248 — MINIATURIZED FINGER CLIP PULSE OXIMETERNonin Medical, Inc.·Product code DQA·1994-12-08
K942453 — GUIDE WIREBoston Scientific Corp·Product code DQX·1994-12-08
K942843 — CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGYRovers Diagnostic Devices·Product code HHT·1994-12-08
K942874 — MODEL #300TO3500 SHOULDER COILMedic, Inc.·Product code LNH·1994-12-08
K943552 — POWDER-FREE GLOVESHealthcare Gloves Sdn Bhd·Product code LYY·1994-12-08
K943804 — BONE SCREWCohort Medical Products Group, Inc.·Product code HWC·1994-12-08
K943858 — POWDER FREE (SILICONIZED) EXAM GLOVESCrocker Industrial Resources Sdn. Bhd.·Product code LYY·1994-12-08
K944024 — STIMU-TAPWahl Clipper Corp.·Product code ISA·1994-12-08
K944067 — PEANUT WAND, MODIFICATIONIdeal Medical, Inc.·Product code GCS·1994-12-08
K944290 — CATHETERS, BILIARY CATHETERS, UROLOGICALBoston Scientific Corp·Product code FFA·1994-12-08
K944299 — KARL STORZ INSULATED BIOPSY FORCEPSKARL STORZ Endoscopy-America, Inc.·Product code GCJ·1994-12-08
K944578 — BIPOLAR CORDBoston Surgical Products, Inc.·Product code GEI·1994-12-08
K944634 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIESBoston Surgical Products, Inc.·Product code GEI·1994-12-08
K944642 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIESBoston Surgical Products, Inc.·Product code GEI·1994-12-08
K944659 — PRODIGYSybron Dental Specialties, Inc.·Product code EBF·1994-12-08
K944751 — COULTER FLOW SETCoulter Corp.·Product code JPK·1994-12-08
K944769 — P.F.C. APICAL PLUGJohnson & Johnson Professionals, Inc.·Product code JDL·1994-12-08
K945082 — CYPRESS MEDICAL PRODUCTS STETHOSCOPECypress Medical Products, Ltd.·Product code LDE·1994-12-08
K945377 — TRELEX NATURAL(R) MESHMeadox Medicals, Div. Boston Scientific Corp.·Product code FTL·1994-12-08
K945420 — CHAKOFF ENDOSCOPYStephen Chakoff, Inc.·Product code FCW·1994-12-08
K945490 — LATEX EXAMINATION GLOVEMasif Healthcare Products Sdn. Bhd.·Product code LYY·1994-12-08
K945587 — CANDELA ELLIPTICAL SPOT HANDPIECECandela Laser Corp.·Product code GEX·1994-12-08
K945717 — ELECTROSURGICAL ENDOSCOPIC CORDBoston Surgical Products, Inc.·Product code GEI·1994-12-08
K924277 — DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDINGChalgren Enterprises, Inc.·Product code HLT·1994-12-07
K936268 — COMFIT BLUE POWDERED EXAMINATION GLOVESWembley Rubber Products (M) Sdn Bhd·Product code LYY·1994-12-07
K940085 — FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01Sense Technology, Inc.·Product code LXM·1994-12-07
K940108 — DIAGNOSTIC ULTRASOUND IMAGING CATHETERBoston Scientific Corp·Product code ITX·1994-12-07
K940173 — CANDELA Q-SWITCHED ALEXANDRITE LASERCandela Laser Corp.·Product code GEX·1994-12-07
K941970 — FAST-PATCHPhysio-Control Corp.·Product code MKJ·1994-12-07
K942856 — POWDER-FREE LATEX EXAMINATION GLOVESPacificlink Exp.Industries Private , Ltd.·Product code LYY·1994-12-07
K942861 — MEDVISION ENVIROMENT/MEDVISION 2.0Evergreen Technologies, Inc.·Product code LMD·1994-12-07
K942962 — GGT QVETPrisma Systems·Product code JQB·1994-12-07
K943006 — CHLORIDE QVETPrisma Systems·Product code CHJ·1994-12-07
K943028 — HDL QVETPrisma Systems·Product code LBS·1994-12-07
K943199 — MOTORIZED DEPTH DOSE APPARATUSMedtec, Inc.·Product code IYE·1994-12-07
K943239 — VISUALINE II HCGSun Biomedical Laboratories, Inc.·Product code JHI·1994-12-07
K943532 — PANORAMIC CORPORATION HDLXPanoramic Corp.·Product code JAA·1994-12-07
K943635 — ULTRA-LINE RONGEURV. Mueller Neuro/Spine·Product code HAE·1994-12-07
K943802 — HP BACK POINTER SYSTEMMedtec, Inc.·Product code IWE·1994-12-07
K943987 — OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGEInnerspace Medical, Inc.·Product code GWM·1994-12-07
K944140 — COMFITWembley Rubber Products (M) Sdn Bhd·Product code LYY·1994-12-07
K944207 — TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.·Product code HLQ·1994-12-07
K944223 — ACCUCONInnovision, Inc.·Product code HQD·1994-12-07
K944355 — NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLESNissho Corp.·Product code FMF·1994-12-07
K944604 — CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMSBeckman-Diagnostic Systems Group·Product code DKZ·1994-12-07
K944605 — CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEMBeckman-Diagnostic Systems Group·Product code LCM·1994-12-07
K945282 — MULTIPLEMi MI Progress Co. , Ltd.·Product code HQY·1994-12-07
K945322 — PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416Emd Chemicals, Inc.·Product code CEO·1994-12-07
K945337 — PHENYTOIN CALIBRATORSDiagnostic Reagents, Inc.·Product code DLJ·1994-12-07
K945341 — MULTIPLEMi MI Progress Co. , Ltd.·Product code HQY·1994-12-07
K945637 — R-MED MOTORIZED LAPAROSCOPIC HANDLER-Med, Inc.·Product code GCJ·1994-12-07
K945657 — DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTERTec II Medical, Inc.·Product code BYD·1994-12-07
K945727 — CATCO NEONATAL PALATE GUARDCatco Medical, Inc.·Product code BRW·1994-12-07
K945745 — ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)Wolfe Tory Medical, Inc.·Product code BTR·1994-12-07
K930284 — METRICIDEMetrex Research Corp.·Product code MED·1994-12-06
K931052 — METRICIDE 28Metrex Research Corp.·Product code MED·1994-12-06
K931466 — PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRIJohnson & Johnson Orthopaedics, Inc.·Product code JWH·1994-12-06
K931592 — METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDEMetrex Research Corp.·Product code MED·1994-12-06
K940065 — SES100Southwest Ergonomics·Product code ISD·1994-12-06
K942350 — CAREPAKPrecision Medical, Inc.·Product code CAF·1994-12-06
K943154 — KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSKARL STORZ Endoscopy-America, Inc.·Product code HRX·1994-12-06
K944125 — ABBOTT LTE INFUSION PUMPAbbott Laboratories·Product code FRN·1994-12-06
K944255 — DMA CALCIUM PLUS PROCEDUREData Medical Associates, Inc.·Product code CJY·1994-12-06
K944377 — ORION'S URINARY DRAINAGE SETRegulatory & Marketing Services, Inc.·Product code KNX·1994-12-06
K944382 — ORION ALL SILICONE FOLEY CATHETERRegulatory & Marketing Services, Inc.·Product code EZL·1994-12-06
K944383 — ORION RED URETHRAL CATHETERRegulatory & Marketing Services, Inc.·Product code EZD·1994-12-06
K944672 — INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICESBoston Scientific Corp·Product code GCJ·1994-12-06
K911820 — GED (GRADUATED ELECTRONIC DECELERATORBehavior Research Institute, Inc.·Product code HCB·1994-12-05
K924646 — OVER THE GUIDEWIRE DILATATION SYSTEMMedovations, Inc.·Product code KNQ·1994-12-05
K933461 — BOEHRINGER MANNHEIM BICARBONATE ASSAYBoehringer Mannheim Corp.·Product code KHS·1994-12-05
K935301 — R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050R & D Batteries, Inc.·Product code HGM·1994-12-05
K935377 — R AND D BATTERIESR & D Batteries, Inc.·Product code HGM·1994-12-05
K935846 — MODEL ACUITY CENTRAL STATIONProtocol Systems, Inc.·Product code DSI·1994-12-05
K940012 — SMARTBRACE ELECTRODEMedical Devices, Inc.·Product code GXY·1994-12-05
K941367 — WEBB-MORLEY SPINE SYSTEMElectro-Biology, Inc.·Product code KWQ·1994-12-05
K942340 — CORTICAL BONE SCREWAcu Med, Inc.·Product code HWC·1994-12-05
K942341 — CANNULATED CANCELLOUS BONE SCREWAcu Med, Inc.·Product code HWC·1994-12-05
K942442 — ACUFEX T-FIX DELIVERY SYSTEMAcufex Microsurgical, Inc.·Product code MIA·1994-12-05
K942565 — ALTAIR-DISC RECORDERBurdick Corp.·Product code DQK·1994-12-05

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