FDA 510(k) clearances — page 1035

176,637 clearances on record, most recent first.

Clearances — page 1035

103,401–103,500 of 176,637

K952025 — ROBOCAPPharmacia, Inc.·Product code JQW·1995-07-26
K952070 — NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANSAmerican Hydro-Surgical Instruments, Inc.·Product code KNF·1995-07-26
K952092 — ERGOMAT 8000 SYSTEMErgo-Air, Inc.·Product code FNM·1995-07-26
K952093 — ERGOMAT 5000 SYSTEMErgo-Air, Inc.·Product code FNM·1995-07-26
K952243 — EXTENSION SET/I.V. SETCoast Medical, Inc.·Product code FPK·1995-07-26
K952247 — BURNSHIELD TRAUMA DRESSINGGolightly International Corp.·Product code MGQ·1995-07-26
K952284 — AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.·Product code CEE·1995-07-26
K952302 — AMUCHINAAmuchina Intl., Inc.·Product code LRJ·1995-07-26
K952419 — STERIGAUZE GEL DRESSINGAcacia Laboratories, Inc.·Product code MGQ·1995-07-26
K952504 — TECNOL TRANSPARENT WOUND DRESSINGTecnol Medical Products, Inc.·Product code MGP·1995-07-26
K952785 — BRIMFIELD PRECISION DETACHABLE SCISSORSpringfield Surgical Instruments·Product code GCJ·1995-07-26
K952832 — DISPOSABLE BIPOLAR ELECTRODENeuro Navigational Corp.·Product code GEI·1995-07-26
K952865 — REMANIUM: 200,CS, 380, AND CDDentauraum, Inc.·Product code EJH·1995-07-26
K952940 — PERSONAL PROGRAMMER 2000Siemens Hearing Instruments, Inc.·Product code ESD·1995-07-26
K952988 — WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SSImplant Center of the Palm Beaches·Product code DZE·1995-07-26
K952989 — WIDE STR-TP-4K, PROS STR, CLY-STR-TP 4Implant Center of the Palm Beaches·Product code DZE·1995-07-26
K953266 — RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTIONResound Corp.·Product code ESD·1995-07-26
K941206 — DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBENew Eder Corp.·Product code HET·1995-07-25
K943308 — MODEL 510 INFANT MONITORGe Medical Systems Information Technologies·Product code BZQ·1995-07-25
K943917 — CAPIOX ARTERIAL FILTERTerumo Medical Corp.·Product code DTM·1995-07-25
K944034 — PERIO-MED DENTAL FLOSSWhitehill Oral Technologies, Inc.·Product code JES·1995-07-25
K944270 — CIT MONOPOLAR LAPAROSCOPIC INSTRMENTSChirurgische Instrumente·Product code HET·1995-07-25
K944450 — SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODEUnimed Surgical Products, Inc.·Product code HGI·1995-07-25
K945949 — KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]Vlm Surgical, Inc.·Product code HFX·1995-07-25
K946047 — HOLGRATH METAL-HUB, EPIDURAL NEEDLEHolgrath Medical Technologies, Inc.·Product code BSP·1995-07-25
K950179 — MEDTRONIC(R) GC III CORONARY GUIDING CATHETERMedtronics Interventional Vascular·Product code DQY·1995-07-25
K950780 — AMSINO CERVICAL SCRAPERAmsino Intl., Inc.·Product code HHT·1995-07-25
K950813 — MOLLRING CUTTERCardio Vascular Concepts, Inc.·Product code DWX·1995-07-25
K950968 — TETRAFILCON A HYDROPHILIC CONTACT LENSESCooperVision, Inc.·Product code LPL·1995-07-25
K951172 — TITANIUM LOW PROFILE CROSS BARAdvanced Spine Fixation Systems, Inc.·Product code MNH·1995-07-25
K951658 — LACTOSORB POP RIVETPoly-Medics,Inc.·Product code JDR·1995-07-25
K951693 — CARESS SANITARY NAPKINSterling U.S.A., Inc.·Product code HHD·1995-07-25
K951984 — WHITE KNIGHT SURGEON'S VESTWhite Knight Healthcare·Product code FYA·1995-07-25
K952187 — RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILERusch, Inc.·Product code KOB·1995-07-25
K952288 — SAS SALMONELLA H C ANTISERUMSa Scientific, Inc.·Product code GRM·1995-07-25
K952563 — THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEMThe Tulip Mfg. Co.·Product code GCT·1995-07-25
K952696 — XENON LIGHT SOURCE MODEL 5121Richard Wolf Medical Instruments Corp.·Product code GCT·1995-07-25
K952845 — HUMID-VENT TRACH-VENTGibeck, Inc.·Product code BYD·1995-07-25
K944669 — FLEXIFLO QUANTUM ENTERAL PUMPAbbott Mfg., Inc.·Product code FRN·1995-07-24
K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.·Product code KXO·1995-07-24
K950914 — RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/VRudolf Riester GmbH & Co. KG·Product code HLJ·1995-07-24
K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko Diagnostic Corp.·Product code KRZ·1995-07-24
K951389 — REUNION BONE SCREW SYSTEMSmith & Nephew Richards, Inc.·Product code HWC·1995-07-24
K952033 — IMAGYN HYSTEROSCOPEImagyn Medical, Inc.·Product code HIH·1995-07-24
K952210 — LORAD STEROLOC IILorad Corp.·Product code IZH·1995-07-24
K952530 — HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGEPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1995-07-24
K952774 — MULTIDEX GELLange Medical Products, Inc.·Product code MGQ·1995-07-24
K952947 — DELPORE SKIN CLOSUREBitco Intl.·Product code FPX·1995-07-24
K953161 — MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTIONMaico Hearing Instruments, Inc.·Product code ETY·1995-07-24
K942910 — DEEPVISONAutomated Medical Products Corp.·Product code GCJ·1995-07-21
K944040 — PLANET THERMOPLASTIC IMMOBILIZATION SYSTEMS & S X-Ray Products, Inc.·Product code IYE·1995-07-21
K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAYMrl Diagnostics·Product code LLM·1995-07-21
K950417 — EPX-310 VIDEO PROCESSOR (ENDOSCOPY)Marks & Murase·Product code FET·1995-07-21
K950695 — DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATIONDepuy Motech·Product code MNH·1995-07-21
K951431 — AQUAGEL LUBRICATING JELLYDepuy Healthcare·Product code KMJ·1995-07-21
K951562 — OMNIPULSE-MAX HOLMIUM LASERTrimedyne, Inc.·Product code GEX·1995-07-21
K951802 — SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KITScimed Life Systems, Inc.·Product code DXT·1995-07-21
K951972 — CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSCabot Medical Corp.·Product code FBO·1995-07-21
K952049 — TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEMTissue Technologies, Inc.·Product code GEX·1995-07-21
K952132 — SAS BRUCELLA AMS ANTISERUMSa Scientific, Inc.·Product code GSM·1995-07-21
K952133 — SAS SALMONELLA O POLY POSITIVE ANTISERUMSa Scientific, Inc.·Product code GRM·1995-07-21
K952134 — SAS SALMONELLA H POLY POSITIVE ANTISERUMSa Scientific, Inc.·Product code GRM·1995-07-21
K952141 — SAS FRANCISELLA TULARENSIS ANTISERUMSa Scientific, Inc.·Product code GSK·1995-07-21
K952143 — SAS BRUCELLA MELITENSIS ANTISERUMSa Scientific, Inc.·Product code GSM·1995-07-21
K952144 — SAS BRUCELLA SUIS ANTISERUMSa Scientific, Inc.·Product code GSM·1995-07-21
K952146 — SAS BRUCELLAS ABORTUS ANTISERUMSa Scientific, Inc.·Product code GSM·1995-07-21
K952397 — VITALOCK SOLID BACKED ACETABULAR SHELLHowmedica Corp.·Product code LPH·1995-07-21
K952548 — CELSITE VENOUS SYSTEMB.Braun Medical, Inc.·Product code LJT·1995-07-21
K952820 — MWCHAC 95 C 12345Midwest City Hearing Aid Center·Product code ESD·1995-07-21
K952821 — MWCHAC 95 FS 12345Midwest City Hearing Aid Center·Product code ESD·1995-07-21
K953036 — DB PUSH-PULL HEARING AIDMidwest City Hearing Aid Center·Product code ESD·1995-07-21
K953038 — DYNAMIC EQ/CLASS DMidwest City Hearing Aid Center·Product code ESD·1995-07-21
K923488 — GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMYApplied Medical Technologies·Product code KNT·1995-07-20
K941809 — VINYL PATIENT EXAMINATION GLOVESCheer & Merit Co., Ltd.·Product code LYZ·1995-07-20
K944228 — HEALTH IMAGES, INC. HI-STANDARDHealth Images, Inc.·Product code LNH·1995-07-20
K944232 — AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYSHaemonetics Corp.·Product code CAC·1995-07-20
K944259 — FEMOSTOP IIRadi Medical Systems AB·Product code DXC·1995-07-20
K945700 — SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMSynthes (Usa)·Product code KWQ·1995-07-20
K946056 — ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)Ampri Rubberware Industries Sdn Bhd·Product code LYY·1995-07-20
K950949 — COULTER MH025ACoulter Corp.·Product code GKZ·1995-07-20
K951394 — KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODEKARL STORZ Endoscopy-America, Inc.·Product code HET·1995-07-20
K951734 — LUMIX 70BEmix U.S.A., Inc.·Product code EAP·1995-07-20
K951918 — SURGICAL TECHNOLOGIES, INC. SYRINGESurgical Technologies, Inc.·Product code FMF·1995-07-20
K952067 — CORDIS STEERABLE GUIDEWIRECordis Corp.·Product code DQX·1995-07-20
K952127 — BOEHRINGER MANNHEIM CHOLESTEROL ASSAYBoehringer Mannheim Corp.·Product code CHH·1995-07-20
K952404 — SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVEAladan Corp.·Product code LYY·1995-07-20
K952574 — KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROSKARL STORZ Endoscopy-America, Inc.·Product code FJL·1995-07-20
K952647 — IL TEST LIPASEInstrumentation Laboratory CO·Product code CHI·1995-07-20
K952681 — STRYKER HUMMER II MICRODEBRIDER SYSTEMStryker Endoscopy·Product code ERL·1995-07-20
K952750 — HUMID-VENT 1Gibeck, Inc.·Product code BYD·1995-07-20
K952786 — TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVESBaxter Healthcare Corp·Product code LYZ·1995-07-20
K952813 — SLT MULTIDIMENSIONAL CONTACT LASER SYSTEMSurgical Laser Technologies, Inc.·Product code GEX·1995-07-20
K952816 — LIPASE FLEX REAGENT CARTRIDGEDupont Medical Products·Product code CHI·1995-07-20
K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.·Product code BZA·1995-07-20
K952844 — HUMID-VENT 2Gibeck, Inc.·Product code BYD·1995-07-20
K952871 — RIDGES PLUSOctostop, Inc.·Product code KPR·1995-07-20
K953037 — CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)Midwest City Hearing Aid Center·Product code ESD·1995-07-20
K953208 — MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURESStandard Welders Supply Co.·Product code BXK·1995-07-20
K942922 — SELECTA 20/60 CHEMISTRY ANALYZERSelect Medical Systems, Inc.·Product code JJE·1995-07-19
K943010 — MAXILUBEMission Pharmacal Co.·Product code KMJ·1995-07-19

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