FDA 510(k) clearances — page 981

176,637 clearances on record, most recent first.

Clearances — page 981

98,001–98,100 of 176,637

K962448 — PRIMALOC CEMENTED HIP SYSTEMOrtho Development Corp.·Product code KWY·1996-09-19
K962525 — ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEMMorwel Corp.·Product code LFL·1996-09-19
K962560 — VITALITY HIP STEMEncore Orthopedics, Inc.·Product code JDI·1996-09-19
K962692 — ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBEZomed Intl.·Product code GEI·1996-09-19
K963197 — ON.SITE ALCOHOLAnsys, Inc.·Product code DML·1996-09-19
K953663 — CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERCordis Webster, Inc.·Product code DRF·1996-09-18
K960061 — STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBEStorz Instrument Co.·Product code HQE·1996-09-18
K960754 — SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp.·Product code QGH·1996-09-18
K960759 — GONOPOX TEST KITMedtex Laboratories, Inc.·Product code JSX·1996-09-18
K961046 — 10B ARGININE BROTHRemel, L.P.·Product code JSM·1996-09-18
K961049 — FLEX NEEDLELighthouse Medical, Inc.·Product code FPA·1996-09-18
K961536 — FLEXSCOPEMatrix Medica, Inc.·Product code GDB·1996-09-18
K962151 — RYDER LACRIMAL INTUBATIONSETRyder Intl. Corp.·Product code OKS·1996-09-18
K962429 — SAFETY VESTJohnson & Johnson Professionals, Inc.·Product code FMQ·1996-09-18
K962441 — PROSPORE(STEARO FOR STEAM STERILIZER)Raven Biological Laboratories, Inc.·Product code FRC·1996-09-18
K962843 — MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEMStarplex Scientific, Inc.·Product code JSM·1996-09-18
K963157 — ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY)Oratec Interventions, Inc.·Product code GEI·1996-09-18
K952220 — MERETEK BREATH TEST FOR H.PYLORI COLLECTION KITMeretek Diagnostics, Inc.·Product code LYR·1996-09-17
K952660 — BRAUN HEMODIALYSIS CATHETERB.Braun Medical, Inc.·Product code MPB·1996-09-17
K960647 — OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONSOsteoimplant Technology, Inc.·Product code JDI·1996-09-17
K960851 — THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSORPro-Tech Services, Inc.·Product code BZQ·1996-09-17
K960942 — LATEX PATIENT EXAMINATION GLOVESiam Sempermed Corp., Ltd.·Product code LYY·1996-09-17
K960984 — SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERSBiomet, Inc.·Product code JDI·1996-09-17
K961186 — DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEMDepuy, Inc.·Product code LPH·1996-09-17
K961239 — DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTRELDepuy, Inc.·Product code FYA·1996-09-17
K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBEApplied Medical Technologies·Product code KNT·1996-09-17
K961526 — PRESS-FIT POROUS SHELLEncore Orthopedics, Inc.·Product code LPH·1996-09-17
K961572 — VERSALOK SCREW ASSEMBLY (PROPOSED NAME)Wrightmedicaltechnologyinc·Product code MNH·1996-09-17
K961745 — BRAUN PERCUTANEOUS INTRODUCER SETB.Braun Medical, Inc.·Product code DYB·1996-09-17
K961920 — CROSS PINMedicinelodge, Inc.·Product code JDW·1996-09-17
K962307 — RHYDER DIAGNOSTIC CATHETERFidus Medical Technology Corp.·Product code DRF·1996-09-17
K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATIONKARL STORZ Endoscopy-America, Inc.·Product code GCM·1996-09-17
K962467 — RV PACING LEADAbbott Laboratories·Product code LDF·1996-09-17
K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGSSmith & Nephew Richards, Inc.·Product code JDJ·1996-09-17
K953238 — DRAGER MICRO VENTDrager, Inc.·Product code CBK·1996-09-16
K954426 — CPR LIFE MASK COMPACT BARRIERCarefree Trading, Inc.·Product code CBP·1996-09-16
K954427 — HELPING HANDKinetic Rehabilitation Instruments, Inc.·Product code ITI·1996-09-16
K960503 — DANTEC DUETDantec Medical, Inc.·Product code FEN·1996-09-16
K961048 — OLYMPUS MH-246R BALLOON SHEATHOlympus America, Inc.·Product code ODG·1996-09-16
K961928 — BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102Biomedix, Inc.·Product code FPA·1996-09-16
K961941 — LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363Bio-Rad·Product code JJY·1996-09-16
K962293 — ENDOSONICS AUTOMATIC PULL BACK DEVICEEndosonics Corp.·Product code ITX·1996-09-16
K962388 — IN THE EAR HEARING AIDUnique Hearing Technology, Inc.·Product code ESD·1996-09-16
K962460 — EG-3800T, VIDEO GASTROSCOPEPentax Precision Instrument Corp.·Product code FDS·1996-09-16
K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]Gynecare Innovation Center·Product code FJL·1996-09-16
K962817 — DRUG CALIBRATOR IIDade Intl., Inc.·Product code DKB·1996-09-16
K962826 — MEDLINE RADIOLOGY-DIAGNOSTIC KITSMedline Industries, Inc.·Product code LRO·1996-09-16
K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETERHollister, Inc.·Product code EXJ·1996-09-16
K962971 — POLYPROPYLENE MESH (VARIOUS SIZES)Davis & Geck, Inc.·Product code FTL·1996-09-16
K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETERQuinton, Inc.·Product code MPB·1996-09-13
K955067 — CLEARVIEW C. DIFF AUnipath , Ltd.·Product code MCB·1996-09-13
K961359 — LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2Bioprocessing, Inc.·Product code JJY·1996-09-13
K961449 — TRACHEOSTOMY TUBES TRACOE-FLEXTracoe Medical GmbH·Product code JOH·1996-09-13
K962319 — NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIESNeoprobe Corp.·Product code IZD·1996-09-13
K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATORCasco Standards·Product code JIX·1996-09-13
K962671 — STA-VWF CALIBRATOR KITAmerican Bioproducts Co.·Product code GJT·1996-09-13
K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGEDade Intl., Inc.·Product code LCR·1996-09-13
K962819 — GENTAMICIN FLEX REAGENT CARTRIDGEDade Intl., Inc.·Product code LCD·1996-09-13
K962820 — CARBAMAZEPINE FLEX REAGENT CARTRIDGEDade Intl., Inc.·Product code KLT·1996-09-13
K963070 — VENIPUNCTURE KITMiller Products and Services·Product code FPA·1996-09-13
K963088 — SHEATH, ELECTROSURGICAL PENCILAspen Laboratories, Inc.·Product code GEI·1996-09-13
K963267 — VANCOMYCIN FLEX REAGENT CARTRIDGEDade Intl., Inc.·Product code LEH·1996-09-13
K963275 — RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEMImmuno Concepts, Inc.·Product code LLL·1996-09-13
K954168 — E100A PULSE OXIMETER FINGER SENSOR/PROBEEpic Medical Equipment Services, Inc.·Product code DQA·1996-09-12
K955012 — MIZUHO RADIOLUCENT HEAD FRAMEMizuho America, Inc.·Product code HBL·1996-09-12
K960192 — POSITRON COINCIDENCE DETECTIONPhilips Medical Systems (Cleveland), Inc.·Product code KPS·1996-09-12
K960836 — DMS-9000O.R. Solutions, Inc.·Product code LRJ·1996-09-12
K960965 — FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211Coeur Laboratories, Inc.·Product code DXT·1996-09-12
K961039 — BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYLDayspring Medical, Inc.·Product code FJI·1996-09-12
K961376 — SMART-TENS, MODEL 456Bio-Medical Research, Ltd.·Product code GZJ·1996-09-12
K961466 — PERCUTANEOUS INTRODUCER SETThomas Medical Products, Inc.·Product code DYB·1996-09-12
K961980 — BIPORE BALLOON DILATATION CATHETERBipore, Inc.·Product code LIT·1996-09-12
K962218 — CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDGCarrington Laboratories, Inc.·Product code MGQ·1996-09-12
K962274 — UNICAP 100Pharmacia, Inc.·Product code DHB·1996-09-12
K962329 — GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10Global Medical Prods, Inc.·Product code FMF·1996-09-12
K962428 — EBS (ESPE BONDING SYSTEM)Espe GmbH & Co. Kg.·Product code KLE·1996-09-12
K962495 — INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)Advanced Cardiovascular Systems, Inc.·Product code MAV·1996-09-12
K962513 — DERMAPLEX HYDROGEL WOUND DRESSINGMaxxim Medical·Product code MGQ·1996-09-12
K962520 — DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823AMesure Technology·Product code FLL·1996-09-12
K962540 — E-TYPE CONTRA ANGLE NAC-ENsk Nakanishi, Inc.·Product code EGS·1996-09-12
K962836 — HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)Hemagen Diagnostics, Inc.·Product code DHR·1996-09-12
K962853 — NEOSONOL.S. Scientific·Product code LQY·1996-09-12
K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERPolymedica Industries, Inc.·Product code FLL·1996-09-12
K960772 — PHOTODERM PL.Esc Medical Systems , Ltd.·Product code GEX·1996-09-11
K961006 — MEDLITE/755 ALEXANDRITE LASER SYSTEMContinuum Biomedical, Inc.·Product code GEX·1996-09-11
K961629 — THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TESTTeco Diagnostics·Product code JLW·1996-09-11
K961800 — HEAD MOUNTED DISPLAYVista Medical Technologies, Inc.·Product code GCJ·1996-09-11
K962104 — AIRLIFT BALLOON RETRACTON SYSTEMOrigin Medsystems, Inc.·Product code GCJ·1996-09-11
K962255 — CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)Clarus Medical Systems, Inc.·Product code EOB·1996-09-11
K962258 — ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIPEthicon Endo-Surgery, Inc.·Product code GAG·1996-09-11
K962313 — MODIFIED LEVEEN NEEDLE ELECTRODERadiotherapeutics Corp.·Product code JOS·1996-09-11
K962330 — AMO ARTHOSCOPESAmerican Microptiks, Inc.·Product code HRX·1996-09-11
K962354 — DIOMED 15, 30, 60 SURGICAL DIODE LASERLifestream Int'L, Inc.·Product code GEX·1996-09-11
K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)Radi Medical Systems AB·Product code GAA·1996-09-11
K962440 — PERTAC II/PERTAC II APLITIPEspe GmbH & Co. Kg.·Product code EBF·1996-09-11
K962442 — HYTAC APLITIP/HYTAC OSBEspe GmbH & Co. Kg.·Product code EBF·1996-09-11
K962493 — ENDOSCOPIC CLIP APPLIERAesculap, Inc.·Product code OCW·1996-09-11
K962510 — HEARTPORT ENDOAORTIC CLAMPHeartport, Inc.·Product code DXC·1996-09-11
K962543 — ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TUNsk Nakanishi, Inc.·Product code EFB·1996-09-11
K962800 — STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIESStryker Instruments·Product code HWE·1996-09-11

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