FDA 510(k) clearances — page 990

176,637 clearances on record, most recent first.

Clearances — page 990

98,901–99,000 of 176,637

K961857 — LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060Graham-Field, Inc.·Product code DQD·1996-07-03
K961907 — RIONET HEARING AID HB53-KAuthorized Hearing Systems, Inc.·Product code ESD·1996-07-03
K961944 — LUNAR REPORT GENERATORLunar Corp.·Product code KGI·1996-07-03
K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)Devon Industries, Inc.·Product code MLS·1996-07-03
K962277 — SELF CURE BONDING AGENTDent Zar, Inc.·Product code KLE·1996-07-03
K962290 — DEROYAL INDUSTRIES, INC. NEONATAL EYE COVERDebusk Technology Corp.·Product code FOK·1996-07-03
K962310 — NON-GENERICClassic Elegance Intl., Inc.·Product code HQY·1996-07-03
K962336 — RADIOGRAPHIC FILM CASSETTESUnidex Group, Inc.·Product code IXA·1996-07-03
K962338 — RADIOGRAPHIC GRIDUnidex Group, Inc.·Product code IXJ·1996-07-03
K962412 — NIKE V8 AND NIKE V12Nike, Inc.·Product code HQY·1996-07-03
K950148 — CHEMMATE(TM) CD43Biotek Solutions, Inc.·Product code DEH·1996-07-02
K951622 — VAX-D THERAPEUTIC TABLEVat-Tech, Inc.·Product code ITH·1996-07-02
K952429 — RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEMRescare , Ltd.·Product code BZD·1996-07-02
K955642 — NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTERNellcor Puritan Bennett, Inc.·Product code DPS·1996-07-02
K960200 — INTROSTAT LEAD INTRODUCERMsi, Inc.·Product code DYB·1996-07-02
K960319 — A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITORA&D Engineering, Inc.·Product code DXN·1996-07-02
K960329 — DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PADContour Medical Technology, Inc.·Product code MKJ·1996-07-02
K960667 — CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEWallace A. Erickson & Co.·Product code EBF·1996-07-02
K960917 — PERCUGLIDEScientific Device Manufacturer, LLC·Product code DRE·1996-07-02
K961088 — NON-CORING NEEDLEArrow Intl., Inc.·Product code FMI·1996-07-02
K961167 — MEDCARE TRACHEOSTOMY CARE TRAYMedcare Medical Group, Inc.·Product code LRQ·1996-07-02
K961324 — GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLESGlobal Medical Prods, Inc.·Product code MIA·1996-07-02
K961329 — BAGRIGHT CHILD RESUSCITATORMedical Marketing Concepts·Product code BTM·1996-07-02
K961330 — BAGRIGHT INFANT RESUSCITATORMedical Marketing Concepts·Product code BTM·1996-07-02
K961358 — ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETERArrow Intl., Inc.·Product code DSP·1996-07-02
K961591 — DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPEVision-Sciences, Inc.·Product code EOB·1996-07-02
K962436 — SUNGLASSESChungsin Kau Optical Mfy. Co. , Ltd.·Product code HQY·1996-07-02
K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPSPolymer Technology Intl.·Product code JMT·1996-07-01
K953795 — VITALMAX 4100Pace Tech, Inc.·Product code CBS·1996-07-01
K955240 — OMEGATRAC BY TEFTECTeftec Corp.·Product code ITI·1996-07-01
K955432 — CPX, CCM, CATH WITH 15% CO2Medical Graphics Corp.·Product code BZM·1996-07-01
K955535 — LOUISVILLE LABS OXYGEN HEAD TENTLouisville Laboratories, Inc.·Product code CBF·1996-07-01
K960347 — SAFETY TROCER WITH SPRINGLOADED OBDURATORSpiess Design, Inc.·Product code HET·1996-07-01
K960947 — SAS SICKLE CELL TESTSa Scientific, Inc.·Product code GHM·1996-07-01
K961307 — SMART SPOTCmt Medical Technologies, Ltd.·Product code LLZ·1996-07-01
K961610 — R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)R&D Systems, Inc.·Product code GKZ·1996-07-01
K961695 — ENDO-TECH LTD., TIPSRatio Design Lab·Product code HFG·1996-07-01
K961873 — ACTIVENT ANTIMICROBIAL VENTILATION TUBESXomed, Inc.·Product code ETD·1996-07-01
K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREData Medical Associates, Inc.·Product code JPZ·1996-07-01
K915704 — AMYLASE (KINETIC) REAGENT SETTech Intl. Co.·Product code CJD·1996-06-28
K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.·Product code JHJ·1996-06-28
K942227 — NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEMC.L. Mcintosh & Assoc., Inc.·Product code DSB·1996-06-28
K953805 — 0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGEAbbott Laboratories·Product code FOZ·1996-06-28
K955564 — RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILERusch, Inc.·Product code JOH·1996-06-28
K960034 — LXN BLOOD GLUCOSE TEST SYSTEMLxn Corp.·Product code CGA·1996-06-28
K960053 — SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEMSelfcare, Inc.·Product code CGA·1996-06-28
K960374 — ULTRACUT 2000Ultralase Technologies, Inc.·Product code LFL·1996-06-28
K961010 — ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTDPrinceton BioMeditech Corp.·Product code DIS·1996-06-28
K961238 — MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1Toshiba America Mri, Inc.·Product code LNH·1996-06-28
K961331 — BAGRIGHT RESPOSABLE CHILD RESUSCITATORMedical Marketing Concepts·Product code BTM·1996-06-28
K961332 — BAGRIGHT RESPOSABLE INFANT RESUSCITATORMedical Marketing Concepts·Product code BTM·1996-06-28
K961335 — GEM PREMIER PLUS MODEL 5500Mallinckrodt Sensor Systems, Inc.·Product code CHL·1996-06-28
K961350 — SYNTHES MINI EXTERNAL FIXATORSynthes (Usa)·Product code KTT·1996-06-28
K961369 — BAGRIGHT RESPOSABLE RESUSCITATORMedical Marketing Concepts·Product code BTM·1996-06-28
K961433 — EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWSElectro-Biology, Inc.·Product code KTT·1996-06-28
K961496 — R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEMHowmedica, Inc.·Product code HRS·1996-06-28
K961497 — PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEMHowmedica, Inc.·Product code HRS·1996-06-28
K961511 — HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLifecore Biomedical, Inc.·Product code LZK·1996-06-28
K961868 — RESPOSABLE CHILD RESUSCITATORMedical Marketing Concepts·Product code BTM·1996-06-28
K961882 — RESPOSABLE INFANT RESUSCITATORMedical Marketing Concepts·Product code BTM·1996-06-28
K961911 — DSL ACTIVE I-HCG ELISADiagnostic Systems Laboratories, Inc.·Product code JHI·1996-06-28
K961938 — STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALSNova Biomedical Corp.·Product code GJS·1996-06-28
K961971 — Q-5000Stryker Endoscopy·Product code FSS·1996-06-28
K962234 — STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)Howard Medical Co.·Product code EFQ·1996-06-28
K953339 — BONESOURCE HYDROXYAPATITE CEMENT (HAC)Osteogenics, Inc.·Product code GXP·1996-06-27
K953590 — COMFITWembley Rubber Products (M) Sdn Bhd·Product code LYY·1996-06-27
K953911 — PHILIPS EASYVISIONPhilips Medical Systems, Inc.·Product code LLZ·1996-06-27
K955495 — RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILERusch, Inc.·Product code BTR·1996-06-27
K955918 — SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREESinochem Ningbo Imp & Exp Corp.·Product code LYY·1996-06-27
K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITGabriel Medical, Inc.·Product code FAT·1996-06-27
K960307 — INDEX SHOEOrthopedic Technology Research, Inc.·Product code IRN·1996-06-27
K960478 — ACCUMETER H. PYLORI TESTChemtrak, Inc.·Product code LYR·1996-06-27
K960496 — LIBERTY LITE PFS SYSTEMUtah Medical Products, Inc.·Product code KPI·1996-06-27
K960746 — SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVESSunmax Enterprise Shanghai Co. , Ltd.·Product code LYZ·1996-06-27
K961230 — EASTERCLAVEEaster Services, Inc.·Product code FLE·1996-06-27
K961251 — PUNCTUR-GUARD WINGED SETBio-Plexus, Inc.·Product code FMI·1996-06-27
K961267 — PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICEPioneer Surgical Technology·Product code JDQ·1996-06-27
K961271 — USCI COMMANDER SERIES GUIDE WIRESC.R. Bard, Inc.·Product code DQX·1996-06-27
K961306 — DELTATALKER WITH INFRAREDPrentke Romich Co.·Product code IQA·1996-06-27
K961310 — STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)Storz Instrument Co.·Product code HQC·1996-06-27
K961404 — MX960 REUSABLE PRESSURE TRANSDUCERMedex, Inc.·Product code DRS·1996-06-27
K961462 — CEDIA THEOPHYLLINE ASSAYBoehringer Mannheim Corp.·Product code KLS·1996-06-27
K961516 — LASER PERIPHERALS INC. BARE FIBERLaser Peripherals, LLC·Product code GEX·1996-06-27
K961690 — CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105Continental X-Ray Corp.·Product code JAA·1996-06-27
K961840 — RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHYRusch Intl.·Product code BTR·1996-06-27
K961878 — SHARPS-TAINERWinfield Industries·Product code FMI·1996-06-27
K942867 — CLEARWATER COLON HYDROTHERAPY MODEL PPC-101Clearwater Colon Hydrotherapy, Inc.·Product code KPL·1996-06-26
K953741 — THERMACYL BLOOD/FLUID WARMERBaxter Healthcare Corp·Product code BSB·1996-06-26
K954572 — MAESTRO CLINICAL REMOTE CONTROLRespironics, Inc.·Product code BZD·1996-06-26
K961169 — RHEUMATOID FACTOR LATEX SLIDE TEST KITRandox Laboratories, Ltd.·Product code DHR·1996-06-26
K961222 — EVRON GELPharmaceutical Innovations, Inc.·Product code KMJ·1996-06-26
K961232 — 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIPBiocompatibles , Ltd.·Product code DQX·1996-06-26
K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCARSil-Med Corp.·Product code GBX·1996-06-26
K961421 — SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEMSynthes (Usa)·Product code JEY·1996-06-26
K961461 — DANESHVAR'S DEVICE (MODIFICATION)Y. Daneshvar·Product code DXC·1996-06-26
K961494 — SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TEMicro-Mega Societe Anonyme·Product code EGS·1996-06-26
K961495 — HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITEBaxter Healthcare Corp·Product code FPA·1996-06-26
K961910 — VIVAGLASS FILIvoclar North America, Inc.·Product code EMA·1996-06-26
K961995 — QUICKSPLINTHeraeus Kulzer, Inc.·Product code EBI·1996-06-26
K962160 — MPM HYDROGEL DRESSING (NON-STERILE)Mpm Medical., Inc.·Product code MGQ·1996-06-26

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