FDA 510(k) clearances — page 958

176,637 clearances on record, most recent first.

Clearances — page 958

95,701–95,800 of 176,637

K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)Coeur Laboratories, Inc.·Product code DTX·1997-03-28
K965239 — PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)Accutron, Inc.·Product code CBN·1997-03-28
K970005 — GYREX 2T-PRESTIGEElscint, Inc.·Product code LNI·1997-03-28
K970018 — FAST TRACT TRANSTRACHEAL PROCEDURE KITL.W. Ward and Assoc., Inc.·Product code LRC·1997-03-28
K970046 — UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)Accutron, Inc.·Product code KHA·1997-03-28
K970053 — ULTRATOMERXBoston Scientific Corp·Product code KNS·1997-03-28
K970130 — HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSINGMedtrex, Inc.·Product code GEI·1997-03-28
K970140 — E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCHValleylab, Inc.·Product code GEI·1997-03-28
K970170 — SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVERichard G. Lindsay·Product code HDB·1997-03-28
K970244 — SCIMED CHOICE FAMILY OF PTCA GUIDE WIRESScimed Life Systems, Inc.·Product code DQX·1997-03-28
K970537 — REXTON MODEL 48 AND 49PPRexton, Inc.·Product code ESD·1997-03-28
K970541 — AESCULAP MODULAR MONOPOLAR ELECTRODESAesculap, Inc.·Product code GEI·1997-03-28
K970565 — MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)Biopsys Medical, Inc.·Product code KNW·1997-03-28
K970737 — B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic·Product code FMI·1997-03-28
K970762 — DUAL LUMEN EMBOLECTOMY CATHETERApplied Medical Resources·Product code DXE·1997-03-28
K970826 — SELECTA-TIP LAPAROSCOPIC SCISSORSMicroline Pentax, Inc.·Product code GEI·1997-03-28
K971057 — COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEMCogent Light Technologies, Inc.·Product code GCT·1997-03-28
K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)Baxter Edwards·Product code HCG·1997-03-27
K964387 — POINT OF USE II SHARPS-A-GATORGraphic Controls Corp.·Product code MMK·1997-03-27
K965091 — TEETHMATE F-1Kuraray Company, Ltd.·Product code EBC·1997-03-27
K970076 — NIPRO DISPOSABLE SOLUTION INFUSION SETNipro Medical Corp.·Product code FPA·1997-03-27
K970111 — JIAWANG POWDER-FREE VINYL EXAMINATION GLOVESShanghai Jiawang Industrial Co. , Ltd.·Product code LYZ·1997-03-27
K970433 — AQUASIL RIGID SMART WETTING IMPRESSION MATERIALDentsply Intl.·Product code ELW·1997-03-27
K970440 — EKONIC DENTAL/MEDICAL MASK (MD 610)Ekonic Company, Ltd.·Product code FXX·1997-03-27
K970625 — POLY-MEDShinemound Enterprise, Inc.·Product code LYY·1997-03-27
K970788 — PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.·Product code FHO·1997-03-27
K970815 — CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.·Product code FXP·1997-03-27
K960849 — MAGNO ALARMCardiac Assist Devices, Inc.·Product code DTG·1997-03-26
K961459 — LEVEL 10 HDIAdvanced Technology Laboratories, Inc.·Product code IYO·1997-03-26
K963775 — MODEL 8800 ASPIRATORMedical Specifics, Inc.·Product code BTA·1997-03-26
K964024 — DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEMDepuy, Inc.·Product code KWP·1997-03-26
K964404 — BACFIX SPINAL FIXATION SYSTEMSpinal Concepts, Inc.·Product code KWP·1997-03-26
K964891 — ORBSHOT KERATOMETEROrbtek, Inc.·Product code MMQ·1997-03-26
K964915 — MAGNESIUMDerma Media Lab., Inc.·Product code JGJ·1997-03-26
K965129 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMWampole Laboratories·Product code LSR·1997-03-26
K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMWampole Laboratories·Product code LSR·1997-03-26
K970340 — AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIERBellab·Product code LZI·1997-03-26
K970402 — DOCTORS REVIEW SYSTEMDigisonics, Inc.·Product code LLZ·1997-03-26
K970904 — WIDEX SENSO DIGITAL (CIC)Widex Hearing Aid Co., Inc.·Product code ESD·1997-03-26
K962970 — SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTIONSpacelabs Medical, Inc.·Product code DSI·1997-03-25
K963203 — BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENTBaxter Healthcare Corp·Product code KDI·1997-03-25
K963325 — SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMSynthes (Usa)·Product code HRS·1997-03-25
K964359 — AVANTA ORTHOPAEDICS TENDON SPACERAvanta Orthopaedics, Inc.·Product code HXA·1997-03-25
K965019 — THE C-FIT FEMORAL HIP SYSTEMCorin USA·Product code JDI·1997-03-25
K970019 — MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENSMenicon U.S.A., Inc.·Product code LPL·1997-03-25
K970036 — FIXATION PIN OR RODUnited States Surgical, A Division of Tyco Healthc·Product code HTY·1997-03-25
K970052 — EXTRACTORRXBoston Scientific Corp·Product code FGE·1997-03-25
K970089 — INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENERInnovasive Devices, Inc.·Product code MBI·1997-03-25
K970161 — HEDGES CORNEAL WETTING PAKHedges Cwp, Inc.·Product code KYG·1997-03-25
K970356 — IRRIGATION/ASPIRATION POLYPECTOMYUnited States Endoscopy Group, Inc.·Product code FDI·1997-03-25
K970538 — VICTORY EYEWEAR COVictory Eyewear Co., Ltd.·Product code HQY·1997-03-25
K970994 — CORE AND COIL ASSEMBLY GUIDEWIRELake Region Mfg., Inc.·Product code EZB·1997-03-25
K954301 — ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)Abbott Laboratories·Product code LFZ·1997-03-24
K962343 — TOXO IGG ELISA TESTGull Laboratories, Inc.·Product code LGD·1997-03-24
K963587 — WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)Wrightmedicaltechnologyinc·Product code MQV·1997-03-24
K964257 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENTBeckman Instruments, Inc.·Product code LKL·1997-03-24
K964841 — ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.·Product code JLS·1997-03-24
K964844 — CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETSConmedcorp·Product code FPA·1997-03-24
K965186 — AXSYM B12Abbott Laboratories·Product code CDD·1997-03-24
K965189 — SPINNAKERTarget Therapeutics·Product code KRA·1997-03-24
K970068 — JELENKO NO.1 (CODE NAME RD-0601)J.F. Jelenko & Co., Inc.·Product code EJT·1997-03-24
K970120 — BILE ACIDS REAGENT SETTeco Diagnostics·Product code KWW·1997-03-24
K970539 — CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.·Product code KHQ·1997-03-24
K970597 — CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)Medical Packaging Corp.·Product code JSM·1997-03-24
K962010 — EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMSPhilips Medical Systems (Cleveland), Inc.·Product code LLZ·1997-03-21
K962376 — KREATIV KURING LIGHT SYSTEMKreativ, Inc.·Product code EBF·1997-03-21
K963057 — FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTERFukuda Denshi USA, Inc.·Product code DSI·1997-03-21
K964003 — METAGEN ALL POLY ACETABULAR CUP SYSTEMMetagen, LLC·Product code JDI·1997-03-21
K964167 — DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)Multidata Systems International Corp.·Product code IYE·1997-03-21
K964522 — ELLIPSE 4Andromeda Medizinische Systeme GmbH·Product code FEN·1997-03-21
K964690 — LIBERTY VALVECleveland Medical Devices, Inc.·Product code KNX·1997-03-21
K965120 — ALLCLENZ WOUND CLEANSERDpt Laboratories, Ltd.·Product code KMF·1997-03-21
K965174 — TRUFILL PVA PARTICLESCordis Neurovascular, Inc.·Product code HCG·1997-03-21
K965181 — CES INFUSION CATHETERCordis Neurovascular, Inc.·Product code KRA·1997-03-21
K970134 — THERMAPREP PLUS OVENTulsa Dental Products, Ltd.·Product code EKM·1997-03-21
K970202 — DEPUY ACE AIM TITANIUM TIBIAL NAILDepuy Ace Medical Co.·Product code HSB·1997-03-21
K970232 — FEMTEX 100% COTTON DENTLE TOUCH TAMPONSRegu-Tech Assoc., Inc.·Product code HEB·1997-03-21
K970247 — SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPESmith & Nephew, Inc.·Product code EOB·1997-03-21
K970293 — FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666Fujifilm Medical System U.S.A., Inc.·Product code LMD·1997-03-21
K970518 — ALGOPLAQUE HYDROCOLLOID DRESSINGLaboratoires Urgo S.A.·Product code MGP·1997-03-21
K970633 — TUSTEX FLAVORED CONDOMSLine One Laboratories·Product code HIS·1997-03-21
K970640 — PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.·Product code IXR·1997-03-21
K970693 — ACRYDERM GEL WOUND DRESSINGAcrymed, Inc.·Product code MGQ·1997-03-21
K970721 — DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEMJohnson & Johnson Medical, Inc.·Product code MCY·1997-03-21
K962565 — POWERED WHEELCHAIROrthofab, Inc.·Product code ITI·1997-03-20
K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4International Biophysics Corp.·Product code DTY·1997-03-20
K963813 — SURE CORE BIOPSY KITInterventional Concepts, Inc.·Product code KNW·1997-03-20
K964336 — CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680Cryomedical Sciences, Inc.·Product code GEH·1997-03-20
K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFTImpra, Inc.·Product code DYF·1997-03-20
K964954 — SUPERLIGHTWheelcare Scooters, Inc.·Product code INI·1997-03-20
K965121 — CANNULAOrigin Medsystems, Inc.·Product code HET·1997-03-20
K965132 — HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBESMallinckrodt Medical·Product code BTR·1997-03-20
K970020 — SIMAR, INC. SURGICAL DRESSINGSimar, Inc.·Product code EFQ·1997-03-20
K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS)Associated Medical Products Co.·Product code LRO·1997-03-19
K951728 — SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPEMira, Inc.·Product code HLI·1997-03-19
K952558 — AARON VAC 2Aaron Medical Industries·Product code HKP·1997-03-19
K952910 — THE SWIRLER NEBULIZERAmici, Inc.·Product code CAF·1997-03-19
K953902 — GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEMMedical Marketing Intl., Inc.·Product code IZH·1997-03-19
K953996 — NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERSNIKKISO CO., LTD.·Product code KDI·1997-03-19
K955461 — TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).VBM Medizintechnik GmbH·Product code BTO·1997-03-19

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