FDA 510(k) clearances — page 1385

176,637 clearances on record, most recent first.

Clearances — page 1385

138,401–138,500 of 176,637

K875083 — KODAK KODAFLEX II CASSETTEEastman Kodak Company·Product code IXA·1988-01-19
K875157 — SHIMADZU CATHETERIZATION C-ARM STAND MH-50AShimadzu Precision Instruments, Inc.·Product code JAA·1988-01-19
K875226 — ESOPHAGEAL OBTURATOR/TRACHEAL TUBESheridan Catheter Corp.·Product code CAO·1988-01-19
K875233 — VARIVIEWER (X-RAY FILM VIEWER)Diversified Diagnostic Products, Inc.·Product code IXC·1988-01-19
K875234 — MON-A-THERM'S SKIN TEMPERATURE SENSORMon-A-Therm, Inc.·Product code FLL·1988-01-19
K875235 — ISOKINETIC SYSTEM, TESTING AND EVALUATIONOrthopedic Systems, Inc.·Product code IKK·1988-01-19
K875270 — INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUSAir-Shields, Inc.·Product code FMT·1988-01-19
K873731 — SAFETY SHIELD KITBallard Medical Products·Product code FXX·1988-01-15
K871712 — MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.Machida America, Inc.·Product code NVE·1988-01-14
K872453 — DEBRISAN ABSORBENT PADPharmacia, Inc.·Product code KOZ·1988-01-14
K872572 — PHARMANET (TM)Pharmacia, Inc.·Product code EFQ·1988-01-14
K872768 — OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.Osteonics Corp.·Product code KWA·1988-01-14
K873205 — TYMPANIC TEMPERATURE SENSORRespiratory Support Products, Inc.·Product code FLL·1988-01-14
K873619 — ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)Arthropedics, Inc.·Product code HRX·1988-01-14
K873795 — M-LENS (THIRTY DEGREE ENDOSCOPE)Opto Vision, Inc.·Product code FEI·1988-01-14
K874133 — MX710 SERIES VASCULAR ACCESS INFUSION SETMedex, Inc.·Product code FPA·1988-01-14
K874414 — HYPODERMIC NEEDLES, SINGLE LUMENHarbor Medical Devices, Inc.·Product code FMI·1988-01-14
K874478 — DYNAFILMFerris Mfg. Corp.·Product code NAD·1988-01-14
K874543 — MODEL OPO-32 IRRIGATION SLEEVEAllergan, Inc.·Product code EIB·1988-01-14
K875012 — ACE/FISCHER PERCUTANEOUS HALF PINSBuckman Co., Inc.·Product code JDW·1988-01-14
K875013 — ACE PERCUTANEOUS 3MM HALF-PINSBuckman Co., Inc.·Product code JDW·1988-01-14
K875022 — ACE/FISHER PERCUTANEOUS TRANSFIXING PINSBuckman Co., Inc.·Product code JDW·1988-01-14
K875086 — ORTHOMET BONE PLATESOrthomet, Inc.·Product code HRS·1988-01-14
K875177 — J&J SCALP VEIN INFUSION SETSCritikon Company, LLC·Product code FOZ·1988-01-14
K875189 — ULTRA TAN PURPLE MINTUltra Tan Intl. AB·Product code LEJ·1988-01-14
K875190 — ULTRA TAN PURPLE PROUltra Tan Intl. AB·Product code LEJ·1988-01-14
K872909 — SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATIONElmed, Inc.·Product code IMG·1988-01-13
K873168 — SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESSSpectramed, Inc.·Product code DRS·1988-01-12
K874162 — OPTEC STAIN CHARACTERIZATION AND MODIFICATION KITPentron Corp.·Product code EBF·1988-01-12
K874336 — PATTERN DISCRIMINATION PERIMETERLkc Technologies, Inc.·Product code HPT·1988-01-12
K874771 — ANGIOMED INTRODUCING SETSAngiomed U.S., Inc.·Product code DWB·1988-01-12
K875034 — SWEDE CHAMP (WHEELCHAIR)Etac Us, Inc.·Product code IOR·1988-01-12
K875035 — SWEDE PETITE (WHEELCHAIR)Etac Us, Inc.·Product code IOR·1988-01-12
K875061 — MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATORSherwood Medical Co.·Product code GIO·1988-01-12
K875122 — DISPOSABLE STERILE SYRINGE FILTERSCorning Medical & Scientific·Product code KET·1988-01-12
K875136 — COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750Lakewood Biochemical Co., Inc.·Product code JSG·1988-01-12
K875151 — ACUSYST-P/3XEndotronics, Inc.·Product code KJH·1988-01-12
K872288 — SONOLAYER-V, SAL-38BToshiba Medical Systems·Product code IYO·1988-01-11
K872895 — HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.Haemonetics Corp.·Product code CAL·1988-01-11
K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530Clinical Sciences, Inc.·Product code LKQ·1988-01-11
K873405 — SUPERVISOR SUN GOGGLES(TM)Eye Communications, Inc.·Product code HQY·1988-01-11
K874147 — QBC BLOOD BANK SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·Product code GKZ·1988-01-11
K874168 — IVT SOUTHEAST ALLERGY SCREENIn Vitro Technologies, Inc.·Product code DHB·1988-01-11
K874169 — IVT NORTHEAST ALLERGY SCREENIn Vitro Technologies, Inc.·Product code DHB·1988-01-11
K874250 — THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.Richmond Products, Inc.·Product code HLP·1988-01-11
K874251 — WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHTRichmond Products, Inc.·Product code HLP·1988-01-11
K874334 — SOLOS SINGLE USE TITANIUM TIPSolos Ophthalmology·Product code HQC·1988-01-11
K874382 — RAICHEM(TM) ALCOHOL REAGENTReagents Applications, Inc.·Product code DML·1988-01-11
K874415 — PRESSURE LIMIT CONTROLDraeger Medical, Inc.·Product code CBK·1988-01-11
K874621 — FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201Cyberfluor, Inc.·Product code CFT·1988-01-11
K874624 — FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301Cyberfluor, Inc.·Product code CEP·1988-01-11
K874626 — REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYSSyva Co.·Product code LCL·1988-01-11
K874840 — BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100ABennett X-Ray Corp.·Product code IZL·1988-01-11
K874876 — GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANELBaxter Healthcare Corp·Product code JWY·1988-01-11
K875069 — BILIRUBIN (TOTAL)Tech-Co, Inc.·Product code CIG·1988-01-11
K875070 — ALBUMIN, BROMCRESOL GREEN DYE-BINDINGTech-Co, Inc.·Product code CIX·1988-01-11
K872823 — DELTA SCRUBPacific Biosystems, Inc.·Product code GEC·1988-01-07
K873158 — MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERSTpl-Cordis, Inc.·Product code DXY·1988-01-07
K873874 — CARDIOFAX-V ECG-8110ANihon Kohden America, Inc.·Product code DSI·1988-01-07
K873995 — BARD DESAI CATHETER ELECTRODEC.R. Bard, Inc.·Product code DRF·1988-01-07
K874296 — INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STERUlti-Med Intl., Inc.·Product code FXX·1988-01-07
K874385 — AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AIDAudiotone, Inc.·Product code ESD·1988-01-07
K874509 — PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABELPlaytex, Inc.·Product code HIL·1988-01-07
K874531 — POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEADIntermedics, Inc.·Product code DTB·1988-01-07
K874575 — PROXIMAL FEMORAL REPLACEMENT PROSTHESISDow Corning Wright·Product code JDG·1988-01-07
K874604 — HISTOBRUSHSpectrum Co.·Product code HHT·1988-01-07
K874809 — REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUMBiotrol, USA, Inc.·Product code JJY·1988-01-07
K874820 — MULTICHEM HDL PRECIPITATING REAGENT #S0914Simmler, Inc.·Product code LBR·1988-01-07
K874891 — FLEXIE THE COPPER SHANK NEEDLESkin Deep, Inc.·Product code KCW·1988-01-07
K874913 — ORTHOMET PIN SYSTEMOrthomet, Inc.·Product code HTY·1988-01-07
K874919 — ORTHOMET WIRE FOR SUTURE, CERCLAGEOrthomet, Inc.·Product code JDQ·1988-01-07
K875009 — IN-THE-EAR HEARING AIDHouse of Hearing Aids, Ltd.·Product code ESD·1988-01-07
K875050 — ORTHOMET BONE SCREWSOrthomet, Inc.·Product code HWC·1988-01-07
K875092 — DEGANIA SILICONE TOURNIQUETDegania Silicone , Ltd.·Product code GAX·1988-01-07
K871881 — MODEL 3000 INFUSION PUMPBd Becton Dickinson Vacutainer Systems Preanalytic·Product code FRN·1988-01-06
K872658 — MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPHDel Mar Avionics·Product code DPS·1988-01-06
K872928 — LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPHFidelity Medical, Inc.·Product code DQK·1988-01-06
K872953 — DISPOSABLE I.V. ADMINISTRATION SETMac Lee Medical Products·Product code FPA·1988-01-06
K873443 — ULTRASPOT MICROMANIPULATORCooper Lasersonics, Inc.·Product code GEX·1988-01-06
K873660 — ROPER-TUKE ELBOWOrthopedic Systems, Inc.·Product code JDB·1988-01-06
K873666 — PALL LEUKOCYTE REMOVAL FILTER, BLOODPall Biomedical Products Co.·Product code CAK·1988-01-06
K873667 — PALL LEUKOCYTE REMOVAL FILTER, PLATELETSPall Biomedical Products Co.·Product code CAK·1988-01-06
K873746 — AUTO SYRINGE MODEL AS20G INFUSION PUMPBaxter Healthcare Corp·Product code FRN·1988-01-06
K873748 — RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KITDeknatel, Inc.·Product code GDW·1988-01-06
K873884 — IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMPY·Product code FRN·1988-01-06
K874467 — SET, ADMINISTRATION INTRAVASCULARKendall Mcgaw Laboratories, Inc.·Product code FPA·1988-01-06
K874520 — MODIFIED AIRWAY TEMPERATURE SENSORMon-A-Therm, Inc.·Product code FLL·1988-01-06
K874521 — MODIFIED THERMAL WELL TEMPERATURE SENSORMon-A-Therm, Inc.·Product code FLL·1988-01-06
K874523 — MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSORMon-A-Therm, Inc.·Product code FLL·1988-01-06
K874524 — MODIFIED SUBCUTANEOUS TEMPERATURE SENSORMon-A-Therm, Inc.·Product code FLL·1988-01-06
K874525 — MODIFIED FOLEY CATHETER/TEMPERATURE SENSORMon-A-Therm, Inc.·Product code KOD·1988-01-06
K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORMallinckrodt Critical Care·Product code FLL·1988-01-06
K874609 — ZEISS VISULAS ARGON LASERCarl Zeiss, Inc.·Product code HQF·1988-01-06
K874643 — KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUSKirschner Medical Corp.·Product code HSD·1988-01-06
K874930 — MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTERIntermedics, Inc.·Product code DTB·1988-01-06
K872617 — EBV-EA TESTGull Laboratories, Inc.·Product code LSE·1988-01-05
K872774 — BETATRON IV SYSTEMCardiac Pacemakers, Inc.·Product code FRN·1988-01-05
K873371 — URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)Bio-Rad·Product code CHQ·1988-01-05
K873893 — LUMICONHamilton Co.·Product code JJQ·1988-01-05
K874033 — IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,XDiagnostic Products Corp.·Product code JHI·1988-01-05

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