FDA 510(k) clearances — page 962

176,637 clearances on record, most recent first.

Clearances — page 962

96,101–96,200 of 176,637

K970057 — AHS OMEGA SPAuthorized Hearing Systems, Inc.·Product code ESD·1997-02-26
K970263 — PM 2002 CC PROLINEPlanmeca Oy·Product code EHD·1997-02-26
K962872 — RESPIFLOTyco Healthcare Deutschaland GmbH·Product code CAF·1997-02-25
K962874 — RESPIFLO/SCurtin & Associates International , Inc.·Product code CAF·1997-02-25
K962981 — CAPIOX SP PUMP HEADTerumo Medical Corp.·Product code KFM·1997-02-25
K963425 — GENZYME DIAGNOSTICS CONTRAST MONOGenzyme Diagnostics·Product code KTN·1997-02-25
K963568 — MASK SURGICALThe Innovative Approach, Corp.·Product code FXX·1997-02-25
K963841 — EZTESTSgm Biotech, Inc.·Product code FRC·1997-02-25
K963917 — HOLDEN-WALKER HUMIDIFIER-NEBULIZER KITHolden Walker Corp.·Product code CAF·1997-02-25
K963970 — ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEMEndocare, Inc.·Product code GEH·1997-02-25
K964142 — MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSMedline Industries, Inc.·Product code KKX·1997-02-25
K964364 — DISPOSABLE APRONInstrument Makar, Inc.·Product code LYU·1997-02-25
K964692 — PERFECTIMJ. Morita USA, Inc.·Product code ELW·1997-02-25
K964768 — THREADLOC DENTAL IMPLANT SYSTEMSSulzer Calcitek, Inc.·Product code DZE·1997-02-25
K964782 — MEDRAD CONTRAST HOLDERMedrad, Inc.·Product code FOX·1997-02-25
K964850 — SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTERBaxter Healthcare Corp·Product code FPA·1997-02-25
K964935 — SUTURE LOCKSmith & Nephew Endoscopy, Inc.·Product code KGS·1997-02-25
K964943 — SUNGLASSES (NON-PRESCRIPTION)Micron Eyewear Manufactory Co., Ltd.·Product code HQY·1997-02-25
K965021 — NON-PRESCRIPTION SUNGLASSESVictory Eyewear Co., Ltd.·Product code HQY·1997-02-25
K965118 — ENDOCARE MONOPOLAR ELECTRODEEndocare, Inc.·Product code FAS·1997-02-25
K965135 — LIFECORE CONICAL ABUTMENTLifecore Biomedical, Inc.·Product code DZE·1997-02-25
K965243 — ENDOCARE ELECTROSURGICAL ELECTRODEEndocare, Inc.·Product code GEI·1997-02-25
K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad Laboratories, Inc.·Product code CHP·1997-02-25
K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.·Product code CFT·1997-02-25
K970297 — OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREEOmni Sales Corp.·Product code LYY·1997-02-25
K970443 — HOLLISTER RETRACTED PENIS POUCHHollister, Inc.·Product code EXI·1997-02-25
K962558 — CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLC·Product code LJC·1997-02-24
K962827 — ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)Marquette Electronics, Inc.·Product code DSI·1997-02-24
K963678 — CARETONE IIAmerican Telecare, Inc.·Product code DQD·1997-02-24
K964013 — MITEK ABSORBABLE TOGGLE ANCHORMitek Products·Product code MAI·1997-02-24
K964752 — KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDERPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1997-02-24
K964778 — HI-STAR MRI IMAGING SYSTEMHealth Images, Inc.·Product code LNH·1997-02-24
K964945 — INNOVASIVE DEVICES ROTATOR CUFF FASTNERInnovasive Devices, Inc.·Product code MBI·1997-02-24
K964951 — KINEMAX PLUS TIBIAL SPACERSHowmedica Corp.·Product code JWH·1997-02-24
K964957 — INTERMITTENT COMPRESSOR SYSTEMEischoco, Inc.·Product code IRP·1997-02-24
K964975 — COHORT DISCECTOMY SYSTEMS (CDS)Cohort Medical Products Group, Inc.·Product code HRX·1997-02-24
K965005 — IAMIN IMPREGNATED GAUZE DRESSINGProcyte Corp.·Product code MGQ·1997-02-24
K960097 — CHARTR EPIcs Medical Corp.·Product code GWJ·1997-02-21
K961982 — TRI-FLOW THREE WAY STOPCOCKNorth, Inc.·Product code FMG·1997-02-21
K962243 — VASOTHERMEhti Medical Corp.·Product code IMJ·1997-02-21
K962703 — THEE THERMASTIMEhti Medical Corp.·Product code IMJ·1997-02-21
K962765 — CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)Cordis Corp.·Product code DQX·1997-02-21
K962850 — TUM-E-VACEthox Corp.·Product code KDH·1997-02-21
K963053 — 9000 SERIES FILTER & FILTER/HMEEnternet Medical, Inc.·Product code CAH·1997-02-21
K963081 — INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONSIndigo Medical, Inc.·Product code GEX·1997-02-21
K964055 — FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)Epic Medical Equipment Services, Inc.·Product code DQA·1997-02-21
K964699 — RHEO DOPPLEX II (RD 2)Huntleigh Technology, Inc.·Product code IYN·1997-02-21
K964712 — PRISM XPVT SYSTEM (210823)Philips Medical Systems (Cleveland), Inc.·Product code KPS·1997-02-21
K964719 — HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATORHudson Respiratory Care, Inc.·Product code BTM·1997-02-21
K964750 — EAGLE 4000 PATIENT MONITORMarquette Electronics, Inc.·Product code LOS·1997-02-21
K964751 — CERALAS DIODE LASER SYSTEM (CERALAS D2)Ceram Optec, Inc.·Product code HQF·1997-02-21
K964770 — COROMETRICS 120 SERIES MATERNAL/FETAL MONITORGe Medical Systems Information Technologies·Product code HGM·1997-02-21
K964773 — DENTEMP ONE STEPMajestic Drug Co., Inc.·Product code EMA·1997-02-21
K964994 — CPI MODEL 6240 50 PSI NEBULIZER COMPRESSORContemporary Products, Inc.·Product code CAF·1997-02-21
K965249 — SPYGLASS ANGIOGRAPHIC CATHETERDaig Corp.·Product code DQO·1997-02-21
K944438 — HEMAGEN CMV IGG KITHemagen Diagnostics, Inc.·Product code LFZ·1997-02-20
K962475 — ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMTransfusion Technologies Corp.·Product code CAC·1997-02-20
K962517 — MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSVHealthdyne Technologies, Inc.·Product code MNS·1997-02-20
K963000 — MAXI LD PTA BALLOON CATHETERCordis Corp.·Product code LIT·1997-02-20
K963207 — QUICKPAC II ONE STEP MARIJUANA (THC) TESTDrial Consultants, Inc.·Product code LDJ·1997-02-20
K963544 — SUPREME II METERChronimed, Inc.·Product code CGA·1997-02-20
K963676 — PRECISION G BLOOD GLUCOSE TESTING SYSTEMMedisense, Inc.·Product code CGA·1997-02-20
K964037 — FLEXIBLE CYSTOSCOPEApplied Fiberoptics, Inc.·Product code FAJ·1997-02-20
K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)W. L. Gore & Associates, Inc.·Product code LYK·1997-02-20
K964452 — HEMATACHEKRichmond Diagnostics, Inc.·Product code GLK·1997-02-20
K964633 — ACCUPACK PREGNANCY TESTGenix Biotek, Inc.·Product code JHI·1997-02-20
K964696 — SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENSSunsoft Corp.·Product code LPL·1997-02-20
K964913 — IRON REAGENTDerma Media Lab., Inc.·Product code JIY·1997-02-20
K964963 — LYPHOCHEK COAGULATION CONTROLBio-Rad·Product code GGN·1997-02-20
K964982 — VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)Johnson & Johnson Clinical Diagnostics, Inc.·Product code CEP·1997-02-20
K965036 — THE ADVANCED OSMOMETER (3900)Advanced Instruments, Inc.·Product code JJM·1997-02-20
K965064 — ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPONRostam , Ltd.·Product code HEB·1997-02-20
K965099 — ACCUMETER H. PYLORI TESTChemtrak, Inc.·Product code LYR·1997-02-20
K965114 — TUMOR MARKER CONTROLDiagnostic Products Corp.·Product code JJY·1997-02-20
K965116 — ABBOTT TESTPACK PLUS HCG COMBO WITH OBCAbbott Laboratories·Product code JHI·1997-02-20
K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.·Product code CFT·1997-02-20
K970198 — IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIESScimedx Corp.·Product code DHN·1997-02-20
K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATORDade Chemistry Systems, Inc.·Product code JIW·1997-02-20
K940942 — COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNERMedison America, Inc.·Product code IYO·1997-02-19
K953978 — ANTERIOR DYNAMIZED SYSTEMAcromed Corp.·Product code KWQ·1997-02-19
K961073 — ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)Atlantis Diagnostics Intl., Inc.·Product code IYO·1997-02-19
K962702 — SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULAGeneral Surgical Innovations·Product code GCJ·1997-02-19
K964305 — NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIESNihon Kohden America, Inc.·Product code CCK·1997-02-19
K964665 — VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)Carbomedics, Inc.·Product code DSY·1997-02-19
K964760 — DORNIER MEDILAS FIBER TOME LASERDornier Medtech America, Inc.·Product code GEX·1997-02-19
K964795 — CEMENTED CALCAR REPLACEMENT FEMORAL STEMJohnson & Johnson Professionals, Inc.·Product code JDI·1997-02-19
K964833 — RMI DUAL FLUID IRRIGATING SYRINGEResearch Medical, Inc.·Product code KYZ·1997-02-19
K965029 — STABLELOC II EXTERNAL FIXATORAcu Med, Inc.·Product code JEC·1997-02-19
K970110 — BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)Bard Medical Div.·Product code ODC·1997-02-19
K970346 — PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENTKairos Orthopaedics·Product code LZO·1997-02-19
K955455 — BAERVELT PARS PLANA GLAUCOMA IMPLANTPharmacia Iovision, Inc.·Product code KYF·1997-02-18
K960363 — BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143Biomet, Inc.·Product code MJT·1997-02-18
K961142 — STRATEC LIA II ANALYZERNichols Institute Diagnostics·Product code JJE·1997-02-18
K963640 — OLYMPUS ACID PHOSPHATASE REAGENTOlympus America, Inc.·Product code CKB·1997-02-18
K964486 — ACCUCURE 3000Lasermed, Inc.·Product code GEX·1997-02-18
K964648 — PROTECT ALL BLOOD PRESSURE CUFF COVERProtect All, Inc.·Product code DXQ·1997-02-18
K964668 — MODELS EXL AND EXS EXTREMITY COIL SETMri Devices Corp.·Product code MOS·1997-02-18
K964857 — RAPISEAL PATCHFusion Medical Technologies, Inc.·Product code FTL·1997-02-18
K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDESJohnson & Johnson Clinical Diagnostics, Inc.·Product code JGP·1997-02-18
K965109 — ELECSYS ESTRADIOL ASSAYBoehringer Mannheim Corp.·Product code CHP·1997-02-18

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