FDA 510(k) clearances — page 923

176,637 clearances on record, most recent first.

Clearances — page 923

92,201–92,300 of 176,637

K974224 — ENDOLYMPHATIC SAC TO MASTOID T-SHUNTExmoor Plastics , Ltd.·Product code ESZ·1998-01-27
K974255 — CD-R STATION AND VRS-2000Electromed Intl., Ltd.·Product code LMD·1998-01-27
K974308 — MEDRAD 1.5T PERIPHERAL VASCULAR ARRAYMedrad, Inc.·Product code MOS·1998-01-27
K974419 — RUSCH SIMPLASTIC COUNCILL TIP CATHETERRusch, Inc.·Product code EZL·1998-01-27
K974613 — VIROTROL IIIBlackhawk Biosystems, Inc.·Product code JJY·1998-01-27
K974621 — PERCUPUMP II WITH EDAE-Z-Em, Inc.·Product code DSB·1998-01-27
K974820 — BREEZY SERIESSunrise Medical, Inc.·Product code IOR·1998-01-27
K974861 — NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.·Product code HQY·1998-01-27
K965153 — HUNTLEIGH FP5000 SYSTEM MODEL FP5000Huntleigh Healthcare, Inc.·Product code JOW·1998-01-26
K971966 — CORONARY VEIN GRAFT TAG MARKERMed-Edge, Inc.·Product code KPK·1998-01-26
K972437 — ROSS ENTERAL FEEDING TUBERoss Products·Product code FPD·1998-01-26
K972642 — PERIO CONTROL IIEstrad B.V.·Product code EIK·1998-01-26
K973875 — RINOFLOW MICRONIZED E.N.T. WASH SYSTEMRespironics, Inc.·Product code KMA·1998-01-26
K974260 — PYRILINKS-D ASSAY KITMetra Biosystems, Inc.·Product code JMM·1998-01-26
K974451 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.·Product code CGA·1998-01-26
K974615 — QUICKSTICK PRO HCG TESTPhamatech·Product code JHI·1998-01-26
K974733 — BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROLBoehringer Mannheim Corp.·Product code LBR·1998-01-26
K974821 — BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TESTQuidel Corp.·Product code LCX·1998-01-26
K965209 — ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)Arrow Intl., Inc.·Product code DSP·1998-01-23
K970866 — FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONERGeorgia Biomedical, Inc.·Product code HIF·1998-01-23
K971078 — HYDROBRUSH (TM) KERATOMEMedjet, Inc.·Product code HQS·1998-01-23
K971844 — MCKINLEY OUTBOUND-2 SYSTEMMckinley, Inc.·Product code FPA·1998-01-23
K972025 — RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KITRadius Intl., Inc.·Product code KNT·1998-01-23
K972102 — RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KITRadius Intl., Inc.·Product code KNT·1998-01-23
K972358 — ORATEC MODEL ENDOTAC PROBEOratec Interventions, Inc.·Product code GEI·1998-01-23
K972722 — ULTIMATE COMPRESSION SCREW SYSTEMOrthopedic Designs, Inc.·Product code HWC·1998-01-23
K972816 — ADVANCED TREATMENT PLANNING SYSTEMAdvanced Radiation Therapy Systems, Inc.·Product code IYE·1998-01-23
K973183 — WOUND DRAINAGE HOLDERR & D Medical Products, Inc.·Product code KGZ·1998-01-23
K973587 — EXMOOR TYMPANOCENTESIS KIT (TK/1)Exmoor Plastics , Ltd.·Product code JZF·1998-01-23
K973713 — 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CARCardiovascular Dynamics, Inc.·Product code ITX·1998-01-23
K973732 — MEGAPULSE IIPti·Product code IMJ·1998-01-23
K974118 — WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLC·Product code IWJ·1998-01-23
K974150 — PROCERA PREPARABLE ABUTMENT SYSTEMNobel Biocare Uas, Inc.·Product code NHA·1998-01-23
K974168 — COOPERSURGICAL INFRARED COAGULATORHogan & Hartson·Product code KNS·1998-01-23
K974497 — INTELECTChattanooga Group, Inc.·Product code GZJ·1998-01-23
K974682 — MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAPBiological Controls, Inc.·Product code FRF·1998-01-23
K974767 — SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPESEndoscopy Division·Product code GCJ·1998-01-23
K974794 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLEWorldwide Medical Technologies, LLC·Product code KNW·1998-01-23
K980068 — WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLEWorldwide Medical Technologies, LLC·Product code KNW·1998-01-23
K971851 — INTERPLEURAL ANESTHESIA CATHETERAxiom Medical, Inc.·Product code BSO·1998-01-22
K971901 — RADIUS LOW PROFILE GASTROSTOMY TUBE KITRadius Intl., Inc.·Product code KNT·1998-01-22
K972022 — ZAK-2000Cardio Systems, Inc.·Product code FNM·1998-01-22
K972451 — COREGISTRATION FUNCTIONNomos Corp.·Product code IYE·1998-01-22
K972488 — KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIESKarl Storz Endoscopy·Product code HET·1998-01-22
K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90Accumed Intl., Inc.·Product code LQL·1998-01-22
K972669 — MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CONPolymer Technology Systems, Inc.·Product code CGA·1998-01-22
K972889 — ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)W & H Dentalwerk·Product code EBW·1998-01-22
K973848 — IBU, INTEGRATED BRACHY THERAPY UNITNucletron Corp.·Product code KPQ·1998-01-22
K973958 — GENERAL PURPOSE ATL NEEDLE GUIDE KITProtek Medical Products, Inc.·Product code ITX·1998-01-22
K974006 — BECTON DICKINSON TWINPAKBd Becton Dickinson Vacutainer Systems Preanalytic·Product code FMI·1998-01-22
K974044 — GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEADDePuy Orthopaedics, Inc.·Product code KWS·1998-01-22
K974066 — RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPSMicroline Pentax, Inc.·Product code GEI·1998-01-22
K974076 — SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBEBio-Logic Systems Corp.·Product code EWO·1998-01-22
K974079 — FORMULA FOR ARCHIMEDBiosound Esaote, Inc.·Product code DPS·1998-01-22
K974122 — ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIAScientific Health Care·Product code MQX·1998-01-22
K974155 — BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENTBaxter Healthcare Corp·Product code DTN·1998-01-22
K974207 — PHILIPS EASYVISION WORKSTATIONPhilips Medical Systems North America, Inc.·Product code LLZ·1998-01-22
K974319 — MIGHTY AIRWheelchairs of Kansas·Product code FNM·1998-01-22
K974365 — MILLS INCUS HA SLEEVEExmoor Plastics , Ltd.·Product code ETB·1998-01-22
K974471 — PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-ASims Deltec, Inc.·Product code LJT·1998-01-22
K974699 — REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINEConsolidated Technologies, Inc.·Product code DKB·1998-01-22
K974822 — AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROLAvl Scientific Corp.·Product code JJY·1998-01-22
K974826 — BM PRECIPATH(R) HDL/LDL-C CONTROLBoehringer Mannheim Corp.·Product code JJY·1998-01-22
K974851 — SAN DIEGO BIOTECH HCG PREGNANCY URINE TESTSan Diego Biotech·Product code JHI·1998-01-22
K974859 — LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.·Product code CFJ·1998-01-22
K972643 — DEPUY AMK 3 PEG PATELLADepuy, Inc.·Product code JWH·1998-01-21
K973396 — QUEST PET IMAGING SYSTEMUgm Medical Systems, Inc.·Product code KPS·1998-01-21
K973624 — NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist Products·Product code IOQ·1998-01-21
K973788 — MICROVASIVE LIPTHOTRIPSY PROBESBoston Scientific Corp·Product code FFK·1998-01-21
K974028 — STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBINGConceptus, Inc.·Product code MKO·1998-01-21
K974030 — CARPAL ENGAGING WRIST FUSION PLATETerray Corp.·Product code HRS·1998-01-21
K974056 — 0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USPHolopack International, LP·Product code CAF·1998-01-21
K974107 — KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)Eastman Kodak Company·Product code LMD·1998-01-21
K974187 — STEALTHSTATION SYSTEMSurgical Navigation Technologies, Inc.·Product code HAW·1998-01-21
K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSARTelemed Systems, Inc.·Product code KNW·1998-01-21
K972034 — MEDPOR OCULAR CONFORMERPorex Surgical, Inc.·Product code HQN·1998-01-20
K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFEDSmiths Industries Medical Systems, Inc.·Product code JOH·1998-01-20
K972614 — TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605Healthdyne Technologies, Inc.·Product code CAW·1998-01-20
K974018 — WILSON-COOK 10 SHOT MULTI-BAND LIGATORWilson-Cook Medical, Inc.·Product code FHN·1998-01-20
K974077 — VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.J. Morita USA, Inc.·Product code EHD·1998-01-20
K974086 — KODAK DIGITAL SCIENCE CARDIAC VIEWEREastman Kodak Company·Product code LLZ·1998-01-20
K974102 — MILTRA IMAGING INC., IMAGE VAULTMitra Imaging, Inc.·Product code LMD·1998-01-20
K974242 — ARGOSY PROGRAMMABLE ONQUEArgosy Electronics·Product code ESD·1998-01-20
K974243 — KERATOME SYSTEMInsight Technologies Instruments, LLC·Product code HMY·1998-01-20
K974281 — ALCON CONTACT LENS CASEAlcon Laboratories·Product code LRX·1998-01-20
K974501 — DIGITAL TINNITUS MASKING SYSTEMPetroff Audio Technologies·Product code KLW·1998-01-20
K974567 — HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWERHewlett-Packard Co.·Product code MSX·1998-01-20
K974719 — PHACOPAKParadigm Medical Industries, Inc.·Product code HQC·1998-01-20
K970572 — DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHETImplant Integration Systems, Inc.·Product code DZE·1998-01-16
K971813 — EMBLAFerguson Medical·Product code OLV·1998-01-16
K972176 — HOME CARE BEAD BEDKinetic Concepts, Inc.·Product code INX·1998-01-16
K972242 — REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEMMedtronic Vascular·Product code MXC·1998-01-16
K972332 — AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEMAesculap, Inc.·Product code GXN·1998-01-16
K972562 — BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLEDElectroscope, Inc.·Product code GEI·1998-01-16
K972857 — SERVOTRONIC EC100 SYSTEMMedicon EG·Product code HBC·1998-01-16
K972967 — OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT; OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENTOsteonics Corp.·Product code JWH·1998-01-16
K973046 — SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAKGeneral Surgical Innovations·Product code GCJ·1998-01-16
K973309 — VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREWVilex, Inc.·Product code HWC·1998-01-16
K973633 — ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SETAtrion Medical Products, Inc.·Product code OKS·1998-01-16
K973830 — POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVESafe Glove , Ltd.·Product code LYY·1998-01-16

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