FDA 510(k) clearances — page 1013

176,637 clearances on record, most recent first.

Clearances — page 1013

101,201–101,300 of 176,637

K955530 — RANIR HI-TECHNOLOGY DENTAL FLOSSRanir/Dcp Corp.·Product code EFW·1995-12-28
K951910 — ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIESXintec Corporation·Product code GEX·1995-12-27
K954275 — MEPORE PLUS (9X15CM)Scott Health Care·Product code KMF·1995-12-27
K950621 — BIOFILL BIOCELLULOSE DRESSING STERILEThe Purdue Frederick Co.·Product code KMF·1995-12-26
K951223 — CK-MB (NAC-ACT)Randox Laboratories, Ltd.·Product code CGS·1995-12-26
K952576 — TRANSPORT CARTBelmont Instrument Corp.·Product code DSP·1995-12-26
K953129 — ESP CULTURE SYSTEM - MYCODifco Laboratories, Inc.·Product code MDB·1995-12-26
K953538 — RM001 REUSABLEAmerican Optisurgical, Inc.·Product code HQC·1995-12-26
K953539 — DM001 DISPOSABLE PACKAmerican Optisurgical, Inc.·Product code HQC·1995-12-26
K954392 — HYTEC AUTOIMMUNE KIT (SS-A)Hycor Biomedical, Inc.·Product code LKJ·1995-12-26
K954551 — DF-1 TERMINAL CAPPacesetter, Inc.·Product code DTB·1995-12-26
K954608 — CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGHBoehringer Mannheim Corp.·Product code DKB·1995-12-26
K954890 — HYTEC AUTOMMUNE KIT (ENA)Hycor Biomedical, Inc.·Product code LLL·1995-12-26
K954891 — HYTEC AUTOIMMUNE KITS (SS-B)Hycor Biomedical, Inc.·Product code LKJ·1995-12-26
K954892 — HYTEC AUTOMIMMUNE KIT (RF)Hycor Biomedical, Inc.·Product code DHR·1995-12-26
K954918 — COMBIDERM ACDConvatec, A Bristol-Myers Squibb Co.·Product code KMF·1995-12-26
K955340 — EUROTROL GAS - ISE CONTROLDirect Solutions·Product code JJS·1995-12-26
K955439 — THE REEL THING (MODIFICATION)Biomedical Devices, Inc.·Product code GBX·1995-12-26
K941352 — SSA-340AToshiba America Medical Systems, In.C·Product code IYN·1995-12-22
K942265 — FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATHVision-Sciences, Inc.·Product code EOB·1995-12-22
K943896 — GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABSDatascope Corp.·Product code DQX·1995-12-22
K945945 — GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NTPhilips Medical Systems North America, Inc.·Product code LNH·1995-12-22
K946230 — ENDURA REUSABLE TENS AND NMES ELECTRODESSelectivemed Components, Inc.·Product code GZJ·1995-12-22
K951429 — FLEXIFLO 6.1 ENTERAL NUTRITION PUMPRoss Products·Product code LZH·1995-12-22
K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZERNational Medical Care, Medical Products Div., Inc.·Product code FJI·1995-12-22
K952889 — INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTSMaterials Conversion Corp.·Product code HET·1995-12-22
K953098 — VOLUMETRIC INFUSION PUMPBaxter Healthcare Corp·Product code FRN·1995-12-22
K953384 — Multi Side Hole lnfusion SystemAngioDynamics, Inc.·Product code QEY·1995-12-22
K953942 — COBRASCAN CX-312Radiographic Digital Imaging, Inc.·Product code LMA·1995-12-22
K953997 — ROTABLATOR ROTATIONAL ANGIOPLASTYHeart Technology Mfg., Inc.·Product code MCW·1995-12-22
K954129 — SPECTRADIGITAL SERIES V250DSPHitachi Medical Corp. of America·Product code KPS·1995-12-22
K954143 — HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMSHitachi Medical Corp. of America·Product code KPS·1995-12-22
K954306 — GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBEGamp & Assoc.·Product code HQB·1995-12-22
K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBEGamp & Assoc.·Product code HQB·1995-12-22
K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBEGamp & Assoc.·Product code HQB·1995-12-22
K954383 — SURELOC CIRCUIT CONNECTORPolamedco, Inc.·Product code BZA·1995-12-22
K954519 — WANG TRANSENDOSCOPIC ASPIRATION NEEDLEMill-Rose Laboratory·Product code FBK·1995-12-22
K954542 — LUNG DIFFUSION MIXTURELiquid Technology Corp.·Product code BXK·1995-12-22
K954562 — GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KITGynetech, Inc.·Product code HHT·1995-12-22
K954601 — NERVE LOCATOR/MONITOR SYSTEM MODIFICATIONRln Systems, Inc.·Product code ETN·1995-12-22
K954634 — RADIOSURGERY VERIFICATION PHANTOMThe Phantom Laboratory, Inc.·Product code IYE·1995-12-22
K954649 — WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAPWilson Greatbatch Technologies, Inc.·Product code GCJ·1995-12-22
K954941 — MIRACLE EAR AND AUDIOTONEMiracle-Ear, Inc.·Product code ESD·1995-12-22
K954949 — TRANSIT INFUSION CATHETER WITH SIDEHOLESCordis Neurovascular, Inc.·Product code KRA·1995-12-22
K955036 — MOBILE X-RAY SYSTEMShimadzu Corp.·Product code IZL·1995-12-22
K955069 — PLAYSKOOLHasbro, Inc.·Product code KKO·1995-12-22
K955249 — SENSOR PADInventive Products, Inc.·Product code IZH·1995-12-22
K955294 — SOF - ABRASION BURTrebay Medical Corp.·Product code EQJ·1995-12-22
K955516 — MONTGOMERY TRACHEOSTOMY SPEAKING VALVEBoston Medical Products, Inc.·Product code JOH·1995-12-22
K955560 — TREBAY SCOPE IRRIGATED CLEARING SLEEVETrebay Medical Corp.·Product code EOB·1995-12-22
K955574 — RESOUND PERSONAL HEARING SYSTEM BTP W/DAIResound Corp.·Product code ESD·1995-12-22
K955593 — EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAYShippert Medical Technologies Corp.·Product code EMX·1995-12-22
K955613 — MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESISMisten Medical Corp.·Product code ETB·1995-12-22
K955615 — MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESISMisten Medical Corp.·Product code ETA·1995-12-22
K940061 — POLYMEDIC SPINAL NEEDLE AND INTRODUCERTechniques Medicales DE Navaree·Product code BSP·1995-12-21
K945268 — OPTUS BRONCHOSCOPESOptus, Inc.·Product code EOQ·1995-12-21
K946074 — ALDERSON BREST DOSIMETRY SYSTEMRadiology Support Devices, Inc.·Product code IYE·1995-12-21
K950916 — CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.·Product code GKZ·1995-12-21
K950917 — CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.·Product code GKZ·1995-12-21
K950918 — CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.·Product code GKZ·1995-12-21
K951073 — CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.·Product code GKZ·1995-12-21
K952108 — EXL-15DP & 20-DP LINACMitsubishi Intl. Corp.·Product code IYE·1995-12-21
K952606 — TARGETT PATCHCutting Edge Technologies, Inc.·Product code KGX·1995-12-21
K953101 — PARAGON IMPLANT SYSTEMCore-Vent Bio-Engineering, Inc.·Product code DZE·1995-12-21
K953486 — MIT ONE STEP PREGNANCY TEST3c Diagnostics, Inc.·Product code JHI·1995-12-21
K953814 — OTOSCAPESoundscape Technologies, Inc.·Product code EWO·1995-12-21
K954390 — CORDIS WESTER STAR CATHETERCordis Webster, Inc.·Product code DRF·1995-12-21
K954395 — CARTO SYSTEMBiosense, Ltd.·Product code DQK·1995-12-21
K954442 — STERILE ISOTONIC SALINE & STERILE WATERMedcare Custom Packaging, Inc.·Product code JOL·1995-12-21
K954456 — THERMOPLASTIC SHIELDMedtec, Inc.·Product code KPY·1995-12-21
K954573 — PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVESTillotson Healthcare Corp.·Product code LZA·1995-12-21
K954574 — PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVESTillotson Healthcare Corp.·Product code LZA·1995-12-21
K954581 — ARC SERIESContinental X-Ray Corp.·Product code IZI·1995-12-21
K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)Staar Surgical Co.·Product code KYB·1995-12-21
K954619 — CORDGUARD IIUtah Medical Products, Inc.·Product code KNA·1995-12-21
K954655 — ROCHE CONTROL SERUM NRoche Diagnostic Systems, Inc.·Product code JJY·1995-12-21
K954656 — ROCHE CONTROL SERUM PRoche Diagnostic Systems, Inc.·Product code JJY·1995-12-21
K954807 — CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.·Product code KHQ·1995-12-21
K954860 — ECHONETHeartlab, Inc.·Product code LLZ·1995-12-21
K955095 — SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEMSierra Battery, Inc.·Product code IZL·1995-12-21
K955233 — EASY BREATHING NASAL STRIPSCorbett Lair, Inc.·Product code LWF·1995-12-21
K955440 — IMMULITE SHBG (MODIFICATION)Diagnostic Products Corp.·Product code CDZ·1995-12-21
K955447 — TYMPANOSTOMY TUBETrebay Medical Corp.·Product code ETD·1995-12-21
K943304 — 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGYOlympus America, Inc.·Product code FCG·1995-12-20
K943307 — 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERYOlympus America, Inc.·Product code GCJ·1995-12-20
K946337 — IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR IISkylark Device Co., Ltd.·Product code EGJ·1995-12-20
K950919 — CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.·Product code GKZ·1995-12-20
K951495 — ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEMBio-Rad Laboratories, Inc.·Product code LGD·1995-12-20
K951718 — HM-SPIROHill-Med, Inc.·Product code BZG·1995-12-20
K953569 — COURIER BALLOON DILATATION CATHETERBoston Scientific Corp·Product code LIT·1995-12-20
K953608 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETERMeadox Medicals, Div. Boston Scientific Corp.·Product code LIT·1995-12-20
K953767 — PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & Sons·Product code FAQ·1995-12-20
K954150 — VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)Green Field Medical Sourcing, Inc.·Product code BTM·1995-12-20
K954296 — BAGRIGHT RESUSCITATORMedical Marketing Concepts·Product code BTM·1995-12-20
K954434 — OLYMPIC INFANT THERMOMETEROlympic Medical Corp.·Product code FLL·1995-12-20
K954515 — ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLAPyramid Biological Corp.·Product code GOM·1995-12-20
K954657 — WAKO AUTOKIT APO BWako Chemicals USA, Inc.·Product code DFC·1995-12-20
K954812 — LYFO(TM) DIFFERIENTAL DISK-PYRMicrobiologics, Inc.·Product code JTO·1995-12-20
K954853 — AUTO SUTURE SUTURE CLOSUREUnited States Surgical, A Division of Tyco Healthc·Product code GCJ·1995-12-20
K955086 — TEST, RHEUMATOID FACTORPolymedco, Inc.·Product code DHR·1995-12-20

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