FDA 510(k) clearances — page 960

176,637 clearances on record, most recent first.

Clearances — page 960

95,901–96,000 of 176,637

K961835 — PROTIME MICROCOAGULATION SYSTEMInternational Technidyne Corp.·Product code GJS·1997-03-12
K965051 — HEARTPORT NEEDLE TROCARHeartport, Inc.·Product code DRC·1997-03-12
K965161 — SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)Sectra-Imtec AB·Product code LMD·1997-03-12
K965182 — RFG-3CFRadionics, Inc.·Product code GXD·1997-03-12
K965254 — WIDEX MODEL SENSO DIGITAL (C9)Widex Hearing Aid Co., Inc.·Product code ESD·1997-03-12
K970037 — TARGOGRIDDaum GmbH·Product code LNH·1997-03-12
K970598 — INTEGRATED VISUALIZATION SYSTEMUrohealth, Inc.·Product code FCW·1997-03-12
K955841 — SLEEP SYSTEM FOR CLINICS & RESEARCHCompumedics Ptd , Ltd.·Product code MNR·1997-03-11
K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMSorenson Critical Care·Product code BSY·1997-03-11
K962605 — PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)Surgicot, Inc.·Product code FRG·1997-03-11
K963001 — LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEARPermeable Technologies, Inc.·Product code LPL·1997-03-11
K963273 — VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATIONSmv America·Product code KPS·1997-03-11
K963388 — VESSEL DILATORMaxxim Medical·Product code DRE·1997-03-11
K963608 — QUANTITATIVE SENTINEL SYSTEMQuantitative Medicine, Inc.·Product code HGM·1997-03-11
K963787 — EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONMConmedcorp·Product code DRX·1997-03-11
K963894 — SMARTGUIDEFerguson Medical·Product code FCG·1997-03-11
K964342 — CYTOPLAST GBROsteogenics Co.·Product code LYC·1997-03-11
K964474 — ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVESAllegiance Healthcare Corp.·Product code KGO·1997-03-11
K964636 — FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEMValleylab, Inc.·Product code GEI·1997-03-11
K964902 — CONTACT LENSES METRO-G 3X (HIOXIFILCON B)Metro Optics of Austin, Inc.·Product code LPL·1997-03-11
K964979 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTERPorous Media Corp.·Product code CAH·1997-03-11
K965004 — C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNERSiemens Medical Solutions USA, Inc.·Product code JAK·1997-03-11
K965012 — LIFESTYLE BREAK THRU (POLYMACON)The Lifestyle Co., Inc.·Product code LPL·1997-03-11
K965058 — NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KITNichols Institute Diagnostics·Product code CDP·1997-03-11
K965082 — SOOTHING WATER-FILLED TEETHERConsolidated Stores Corp.·Product code KKO·1997-03-11
K965107 — MEDLINE ADMISSION KITSMedline Industries, Inc.·Product code FXX·1997-03-11
K965170 — ROCCOBAROCCO & PRO-DYNAMIXMichelangelo, Inc.·Product code HQY·1997-03-11
K965211 — VISTA BRITE TIP CATHETERSCordis Corp.·Product code DQY·1997-03-11
K970063 — SERIES 7600 MOBILE DIGITAL C-ARMGe Dec Medical Systems·Product code OWB·1997-03-11
K970079 — PROXIMATE DISPOSABLE SKIN STAPLEREthicon Endo-Surgery, Inc.·Product code GAG·1997-03-11
K970240 — DIFFUSER PANELFocused Viewer, Inc.·Product code IXC·1997-03-11
K970256 — INTRAORAL MANDIBULAR DISTRACTION DEVICEMedicon EG·Product code JEY·1997-03-11
K970313 — PREPOWDERED LATEX EXAMINATION GLOVEBesglove Healthcare Sdn. Bhd.·Product code LYY·1997-03-11
K970372 — GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITSPrecision Endoscopy of America, Inc.·Product code FDF·1997-03-11
K970427 — KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPEKarl Storz Endoscopy·Product code FGB·1997-03-11
K970430 — ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCIMidwest City Hearing Aid Center·Product code ESD·1997-03-11
K970560 — URIC ACID (LIQUID) REAGENT SETPointe Scientific, Inc.,·Product code KNK·1997-03-11
K961269 — PULSEMASTERAmerican Dental Technologies, Inc.·Product code GEX·1997-03-10
K962323 — IMMULITE OPIATES SCREEN/CONTROL MODULEDiagnostic Products Corp.·Product code DJG·1997-03-10
K964231 — NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)North American Sterilization & Packaging Co.·Product code KMF·1997-03-10
K964538 — R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEMBoston Scientific Corp·Product code LJT·1997-03-10
K964604 — BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATIONBiotronik, Inc.·Product code DTB·1997-03-10
K964865 — PVK-720ST ENDOCAVITARY TRANSDUCERToshiba America Medical Systems, In.C·Product code ITX·1997-03-10
K964909 — ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESISXomed, Inc.·Product code ETB·1997-03-10
K964910 — AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERSAlpha-Omega Services, Inc.·Product code JAQ·1997-03-10
K964959 — VASCUTEK TWILLWEAVE VASCULAR GRAFTVascutek, Ltd.·Product code DSY·1997-03-10
K964973 — GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIRGish Biomedical, Inc.·Product code DTN·1997-03-10
K965040 — INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOLJohnson & Johnson Medical, Inc.·Product code HHW·1997-03-10
K965043 — 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIEMinnesota Mining and Mfg. Co.·Product code FXX·1997-03-10
K965115 — ROUND WINDOW CATHNeuro-Biometrix, Inc.·Product code ETD·1997-03-10
K965146 — FLAT CLOSED WOUND DRAIN WITH TROCARAxiom Medical, Inc.·Product code GBX·1997-03-10
K965240 — SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON LBeckman Instruments, Inc.·Product code JJE·1997-03-10
K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROLSimplicity Diagnostics, Inc.·Product code MJX·1997-03-10
K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKSMedline Industries, Inc.·Product code LRO·1997-03-10
K970357 — EPISCREENEpitope, Inc.·Product code PJD·1997-03-10
K970360 — MITEK SUTURE RETROGRADERMitek Products·Product code HWQ·1997-03-10
K970385 — SPARFLOZACIN, 5 MCG, SENSI-DISCBecton Dickinson Microbiology Systems·Product code JTN·1997-03-10
K970387 — HUMAN CHORIONIC GONADOTROPIN METHODDade Chemistry Systems, Inc.·Product code DHA·1997-03-10
K970477 — HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KITSebia·Product code CFE·1997-03-10
K970666 — LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROLBio-Rad·Product code DIF·1997-03-10
K944180 — MODEL 700Memtec Corp.·Product code DSH·1997-03-07
K961892 — SPECKTIN-LA TEST SETAnalytical Control Systems, Inc.·Product code GFO·1997-03-07
K962446 — SHARPLAN RUBY LASER SYSTEMSharplan Lasers, Inc.·Product code GEX·1997-03-07
K962545 — DENTAL, MEDICAL INSTRUMENT CASES & CASSETTESterilization Cassette Systems, Inc.·Product code KCT·1997-03-07
K962578 — HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LLL·1997-03-07
K962719 — HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LLL·1997-03-07
K962720 — HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LLL·1997-03-07
K962722 — HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LLL·1997-03-07
K962727 — HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LLL·1997-03-07
K962728 — HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LLL·1997-03-07
K962729 — HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODYHycor Biomedical, Inc.·Product code DHR·1997-03-07
K962730 — HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LRM·1997-03-07
K962731 — HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODYHycor Biomedical, Inc.·Product code LLL·1997-03-07
K964528 — (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINTBenz Research and Development Corp.·Product code LPL·1997-03-07
K964924 — OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)Osteoimplant Technology, Inc.·Product code LPH·1997-03-07
K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)Ortho Diagnostic Systems, Inc.·Product code GKZ·1997-03-06
K954488 — ROLLER ELECTRODEOlympus America, Inc.·Product code HIH·1997-03-06
K960072 — SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AXBiochem Immunosystems (U.S.), Inc.·Product code GKZ·1997-03-06
K962327 — SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICESekure Seat Corp.·Product code FMQ·1997-03-06
K962547 — CARDIOSERV PMarquette Electronics, Inc.·Product code DRO·1997-03-06
K962781 — COROMETRICS MODEL 510 AND 511 MONITORGe Medical Systems Information Technologies·Product code BZQ·1997-03-06
K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULINBeckman Instruments, Inc.·Product code DEW·1997-03-06
K964066 — DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)C.R. Bard, Inc.·Product code LJT·1997-03-06
K964385 — ELIAS ANA-HEP-2Elias U.S.A., Inc.·Product code LJM·1997-03-06
K964609 — ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBEArray Medical, Inc.·Product code JBP·1997-03-06
K964843 — IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENTBeckman Instruments, Inc.·Product code JZH·1997-03-06
K964890 — ANATOM 2000Analogic Corp.·Product code JAK·1997-03-06
K964939 — THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUSCreative Biomedics, Inc.·Product code BZC·1997-03-06
K964962 — SENTURA SURGICAL GLOVESMaxxim Medical·Product code KGO·1997-03-06
K964967 — BIOCOR 200 HIGH PERFORMANCEOXYGENATORMinntech Corp.·Product code DTZ·1997-03-06
K964980 — ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIMMaxxim Medical·Product code KGO·1997-03-06
K964988 — COULTER AC.T SERIES ANALYZERCoulter Corp.·Product code GKZ·1997-03-06
K965055 — IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPESImagyn Medical, Inc.·Product code HET·1997-03-06
K965070 — SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp.·Product code QGH·1997-03-06
K965078 — 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPSNeuro Navigational Corp.·Product code GWG·1997-03-06
K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENTBeckman Instruments, Inc.·Product code DEW·1997-03-06
K965194 — MEDICOM, TENS ELECTRODESMedicotest A/S·Product code GXY·1997-03-06
K970087 — CR PERFECTChimera Research & Chemical, Inc.·Product code CGX·1997-03-06
K970124 — LIPASE REAGENT SET (COLIPASE METHOD)Teco Diagnostics·Product code CET·1997-03-06
K970212 — LEVOFLOXACIN, 5MCG, SENSI-DISCBecton Dickinson Microbiology Systems·Product code JTN·1997-03-06

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