FDA 510(k) clearances — page 937

176,637 clearances on record, most recent first.

Clearances — page 937

93,601–93,700 of 176,637

K972963 — MODIFIED CEDIA DAU PCP ASSAYBoehringer Mannheim Corp.·Product code LCM·1997-09-22
K972969 — QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.·Product code GIO·1997-09-22
K973069 — SYNCHRON SYSTEMS METHADONE REAGENTBeckman Instruments, Inc.·Product code DJR·1997-09-22
K965154 — TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVEAlbert Browne , Ltd.·Product code LRT·1997-09-19
K971067 — DIGI-INJECTORMedical Instrument Development Laboratories, Inc.·Product code MRH·1997-09-19
K971569 — DINAMAP MPS PORTABLE MONITORJohnson & Johnson Medical, Inc.·Product code MSX·1997-09-19
K971586 — DIGENE CERVICAL BRUSHDigene Corp.·Product code HHT·1997-09-19
K971728 — PIONEER ELEC-TROCAR DEVICEPioneer Surgical Technology·Product code GEI·1997-09-19
K971913 — GR100F URINE FLOWMETERAlbyn Medical , Ltd.·Product code EXY·1997-09-19
K971917 — KENTRON'S ISOLATION GOWNKentron Health Care, Inc.·Product code FYC·1997-09-19
K971984 — AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)Microvena Corp.·Product code MCW·1997-09-19
K972008 — ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODESEuropean Surgical, Inc.·Product code GEI·1997-09-19
K972325 — PULSEMASTER 1000 ST DENTAL LASER SYSTEMAmerican Dental Technologies, Inc.·Product code GEX·1997-09-19
K972347 — MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASERLumenis, Inc.·Product code GEX·1997-09-19
K972393 — INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)Sulzer Orthopedics, Inc.·Product code LPH·1997-09-19
K972410 — IMPERVIOUS ISOLATION GOWNKentron Health Care, Inc.·Product code FYC·1997-09-19
K972415 — MINISITE*BIPOLAR FORCEPS** DEVICEUnited States Surgical, A Division of Tyco Healthc·Product code GEI·1997-09-19
K972458 — LYOCELL WOUND DRESSING/SURGICAL SPONGECourtaulds Fibers, Inc.·Product code MGP·1997-09-19
K972568 — DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMDepuy, Inc.·Product code MNH·1997-09-19
K972599 — ACUFEX SCREW CANNULASmith & Nephew Endoscopy, Inc.·Product code HWC·1997-09-19
K972651 — IN-SLINGInfluence, Inc.·Product code OTN·1997-09-19
K972679 — ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)Ethicon Endo-Surgery, Inc.·Product code GCJ·1997-09-19
K972692 — MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERALZimmer, Inc.·Product code HSB·1997-09-19
K972781 — OT-1Prism Therapeutics, LLC·Product code FED·1997-09-19
K972785 — CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVESAnsell Perry·Product code LYY·1997-09-19
K972901 — AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDAmerican Biosurgical, Inc.·Product code GEI·1997-09-19
K972958 — LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULASLysonix, Inc.·Product code GCJ·1997-09-19
K973114 — SILICONE BILIARY STENT/BILIARY CATHETERSpecialty Surgical Products, Inc.·Product code FGE·1997-09-19
K962379 — SEAGER ELECTROEJACULATORNational Rehab Hospital·Product code LNL·1997-09-18
K970780 — ONE-WAY VALVE (WITH CONNECTOR)Instrumentation Industries, Inc.·Product code CBP·1997-09-18
K971543 — LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMPKaweco GmbH·Product code HGX·1997-09-18
K972311 — MODEL 20 BIPOLAR COAGULATORBoston Surgical Products, Inc.·Product code GEI·1997-09-18
K972317 — MONTGOMERY THYROPLASTY IMPLANT SYSTEMBoston Medical Products, Inc.·Product code MIX·1997-09-18
K972424 — SILENTNITEGlidewell Laboratories·Product code LRK·1997-09-18
K972493 — NIPRO DISPOSABLE SOLUTION INFUSION SETNipro Medical Corp.·Product code FPA·1997-09-18
K972505 — RESUABLE HOT BIOPSY FORCEPSUnited States Endoscopy Group, Inc.·Product code KGE·1997-09-18
K972527 — PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTSQuality System Consulting·Product code FPA·1997-09-18
K972540 — S-357 VIDEO IMAGING SYSTEMSopro·Product code FET·1997-09-18
K972949 — AURELUX BIO Y85PFAurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-18
K973101 — PROSTATE SPECIFIC ANTIGEN METHODDade Chemistry Systems, Inc.·Product code LTJ·1997-09-18
K970589 — MICROETCHER APDanville Engineering, Inc.·Product code KOJ·1997-09-17
K971145 — GLUCOSITE TEST SYSTEMGds Technology, LLC·Product code CGA·1997-09-17
K971508 — RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTUREBio-Whittaker, Inc., A Cambrex Co.·Product code KIR·1997-09-17
K972283 — SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULTSims·Product code BTM·1997-09-17
K972290 — ACS HI-TORQUE RULER GUIDE WIREGuidant Corp.·Product code DQX·1997-09-17
K972301 — BIG BEN SQUARE, BIG BEN ROUNDRudolf Riester GmbH & Co. KG·Product code DXQ·1997-09-17
K972417 — THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEMBicon, Inc.·Product code DZE·1997-09-17
K972827 — IPS EMPRESS COSMO INGOTIvoclar North America, Inc.·Product code EIH·1997-09-17
K972850 — SUNGLASSESIndoptica, S.A.·Product code HQY·1997-09-17
K972875 — COSMOPOSTIvoclar North America, Inc.·Product code ELR·1997-09-17
K973016 — NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASSOptimaxx Intl.·Product code HQY·1997-09-17
K963865 — 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830SArrow Intl., Inc.·Product code DSP·1997-09-16
K971046 — HANDIFLEXHandiflex Corp.·Product code JFB·1997-09-16
K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAYOpportunity, Inc.·Product code EFQ·1997-09-16
K971089 — OPPORTUNITY, INC. LACERATION TRAYOpportunity, Inc.·Product code KKX·1997-09-16
K971090 — OPPORTUNITY DRESSING CHANGE TRAYOpportunity, Inc.·Product code KMF·1997-09-16
K971091 — OPPURTUNITY TRACHEOSTOMY CARE KITOpportunity, Inc.·Product code KMF·1997-09-16
K971093 — OPPORTUNITY I.V. START KITOpportunity, Inc.·Product code MGP·1997-09-16
K971095 — OPPORTUNITY SUTURE REMOVAL KITOpportunity, Inc.·Product code EFQ·1997-09-16
K971470 — MICRO21 WITH CEREBROSPINAL FLUIDTriangle Biomedical Sciences, Inc.·Product code JOY·1997-09-16
K971923 — DRAGER-VAPOR 2000Draeger Medical, Inc.·Product code CAD·1997-09-16
K972313 — THE MAESTRO SYSTEMBioHorizons Implant Systems, Inc.·Product code DZE·1997-09-16
K972354 — ABBOTT CELL-DYN 3200 SYSTEMAbbott Laboratories·Product code GKZ·1997-09-16
K972398 — STEALTHSTATION PASSIVE INSTRUMENT OPTIONSurgical Navigation Technologies, Inc.·Product code HAW·1997-09-16
K972573 — LIQCRYLIC PRO DENTAL RESINDentsply Intl.·Product code EBI·1997-09-16
K972890 — ENLIGHT (TENTATIVE NAME)Sybron Dental Specialties, Inc.·Product code DYH·1997-09-16
K972943 — AURECAST 92Aurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-16
K963926 — AXSYM CA 15-3Abbott Laboratories·Product code MOI·1997-09-15
K971315 — AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.·Product code FCL·1997-09-15
K972261 — RIVETTI-LEVINSON INSTRALUMINAL SHUNTIntegra Neurocare, LLC·Product code DWF·1997-09-15
K972262 — FIRST PICC CATHETERBecton Dickinson Infusion Therapy Systems, Inc.·Product code FOZ·1997-09-15
K972263 — FIRST PICC CATHETER WITH DUAL LUMENSBecton Dickinson Infusion Therapy Systems, Inc.·Product code FOZ·1997-09-15
K972264 — FIRST MIDCATH CATHETERBecton Dickinson Infusion Therapy Systems, Inc.·Product code FOZ·1997-09-15
K972296 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEMGe Medical Systems, Inc.·Product code MOS·1997-09-15
K972312 — SIEMENS ORTHOPHOS DS/DS CEPHSiemens AG·Product code EHD·1997-09-15
K972592 — 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)Elscint, Inc.·Product code MOS·1997-09-15
K973044 — DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMPDisetronic Medical Systems·Product code LZG·1997-09-15
K960884 — TELE TRENS TM 10Life Sensing Instrument Company, Inc.·Product code DSI·1997-09-12
K963711 — BABY DOPPLEX (3000)Huntleigh Healthcare, Inc.·Product code HGM·1997-09-12
K970544 — DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESISDepuy, Inc.·Product code KYJ·1997-09-12
K971594 — FLOW-RITEPulpdent Corp.·Product code EBF·1997-09-12
K971727 — DCI WATER PURIFIERDental Components, Inc.·Product code EIA·1997-09-12
K971762 — BELLEGLASS HP ENAMEL REPAIR MATERIALSybron Dental Specialties, Inc.·Product code EBF·1997-09-12
K972009 — PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVETillotson Healthcare Corp.·Product code KGO·1997-09-12
K972248 — NELLCOR PURITAN BENNETT GEMININellcor Puritan Bennett, Inc.·Product code CBK·1997-09-12
K972249 — ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CDPelton & Crane Co.·Product code EHD·1997-09-12
K972254 — FIRST MIDCATH CATHETERBecton Dickinson Infusion Therapy Systems, Inc.·Product code FOZ·1997-09-12
K972256 — FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)Fujifilm Medical System U.S.A., Inc.·Product code LLZ·1997-09-12
K972289 — MIDAS REX MOTORMidas Rex Pneumatic Tools, Inc.·Product code HBB·1997-09-12
K972306 — POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICEP.T. Irama Dinamika Latex·Product code LZA·1997-09-12
K972475 — AURADAPT AUBTMENT SYSTEMNobel Biocare Uas, Inc.·Product code NHA·1997-09-12
K973072 — WAKO NEFA LINEARITY SETWako Chemicals USA, Inc.·Product code JJX·1997-09-12
K973102 — LIDOCAINE EIA ASSAYDiagnostic Reagents, Inc.·Product code KLR·1997-09-12
K973133 — BIG BAG 3000 PRESSURE INFUSORByron Medical·Product code FRN·1997-09-12
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEMBehring Diagnostics, Inc.·Product code DBF·1997-09-12
K973388 — DENTIN CONDITIONING AND ADHESIVE (BOND 1)Jeneric/Pentron, Inc.·Product code KLE·1997-09-12
K962422 — INFIMED DENTAL SYSTEMInfimed, Inc.·Product code EHD·1997-09-11
K964624 — SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEMSiemens Medical Solutions USA, Inc.·Product code DSI·1997-09-11
K964755 — MICROJET CAVITY PREPARATION SYSTEMMidwest Dental Products Corp.·Product code KOJ·1997-09-11
K965160 — HP ORVUE INTRA-OP (M2510A)Hewlett-Packard GmbH·Product code BSZ·1997-09-11

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