FDA 510(k) clearances — page 1396

176,637 clearances on record, most recent first.

Clearances — page 1396

139,501–139,600 of 176,637

K873245 — AR DIACOAT SINGLE VISION LENSESSeiko Optical Products of America, Inc.·Product code HQG·1987-10-05
K873435 — LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SETLevel 1 Technologies, Inc.·Product code KOD·1987-10-05
K873516 — KAWASUMI BLOOD TUBING LINEKawasumi Laboratories Co., Ltd.·Product code FJK·1987-10-05
K873649 — FLEX GOLDFlexmedics·Product code EJF·1987-10-05
K873705 — CARERITE FACE MASKCost Rite Health Products, Inc.·Product code FXX·1987-10-05
K873831 — EAR AND EYE SPONGESOrmed Mfg., Inc.·Product code EFQ·1987-10-05
K871241 — ANSWER OVULATION TEST KITArmkel, LLC·Product code CEP·1987-10-02
K872775 — LEUCOPREP BRAND TUBEBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JCF·1987-10-02
K873037 — CON-DOA (TM) DRUGS OF ABUSE URINE CONTROLDiagnostic Products Corp.·Product code DIF·1987-10-02
K873303 — BINAX L.S. TSH IRMA TEST KITBinax, Inc.·Product code JLW·1987-10-02
K873323 — SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412Lakewood Biochemical Co., Inc.·Product code JSJ·1987-10-02
K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331Lakewood Biochemical Co., Inc.·Product code JSD·1987-10-02
K873325 — SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBELakewood Biochemical Co., Inc.·Product code JSG·1987-10-02
K873326 — SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080Lakewood Biochemical Co., Inc.·Product code JSJ·1987-10-02
K873327 — SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330Lakewood Biochemical Co., Inc.·Product code JSJ·1987-10-02
K873328 — SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252Lakewood Biochemical Co., Inc.·Product code JSG·1987-10-02
K873329 — HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330Lakewood Biochemical Co., Inc.·Product code JSI·1987-10-02
K873333 — WAKO(TM) AUTOKIT ALPWako Chemicals USA, Inc.·Product code CJE·1987-10-02
K873334 — WAKO(TM) AUTOKIT CALCIUMWako Chemicals USA, Inc.·Product code CIC·1987-10-02
K873335 — WAKO(TM) AUTOKIT UREA NWako Chemicals USA, Inc.·Product code CDQ·1987-10-02
K873365 — CREATININE REAGENTSigma Diagnostics, Inc.·Product code CGX·1987-10-02
K873538 — ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHODE.I. Dupont DE Nemours & Co., Inc.·Product code JXM·1987-10-02
K873547 — TITAN GEL HDL CHOLESTEROL KITHelena Laboratories·Product code LBT·1987-10-02
K873551 — CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95Em Diagnostic Systems, Inc.·Product code CIG·1987-10-02
K873622 — ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METHE.I. Dupont DE Nemours & Co., Inc.·Product code DKZ·1987-10-02
K873662 — WINK-EASE PERSONAL PROTECTIVE EYEWEAREye Pro Medical Products, Inc.·Product code HOY·1987-10-02
K873697 — MULTICHEM CALCIUM S0910Simmler, Inc.·Product code CIC·1987-10-02
K873703 — LYSINE IRON AGAR (LIA) PRODUCT #T3046Lakewood Biochemical Co., Inc.·Product code JSH·1987-10-02
K873704 — MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053Lakewood Biochemical Co., Inc.·Product code JSH·1987-10-02
K873707 — CIPROFLOXACIN 5 MCG SUSCEPTIBILITY DISKOrganon Teknika Corp.·Product code JTN·1987-10-02
K873716 — ADULT WALKING HEEL PRODUCT NO. 4183-130Martin Medical·Product code LDF·1987-10-02
K873717 — CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135Martin Medical·Product code LGF·1987-10-02
K873718 — CHILD WALKING HEEL PRODUCT NO. 4183-132Martin Medical·Product code LGF·1987-10-02
K873719 — CAST CUTTER, 115V MODEL NO. 4183-106Martin Medical·Product code LGH·1987-10-02
K873720 — CAST CUTTER, 230V MODEL NO. 4183-107Martin Medical·Product code LGH·1987-10-02
K873722 — PEDESTAL WALKING HEEL PRODUCT NO. 4183-133Martin Medical·Product code LGF·1987-10-02
K873829 — CIPRO SENSITIVITY DISKSDifco Laboratories, Inc.·Product code JTN·1987-10-02
K871964 — SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.Siegen Corp.·Product code GWF·1987-10-01
K872517 — TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEMD. E. Hokanson, Inc.·Product code JOM·1987-10-01
K872578 — MDS-90 ARGON DYE LASER FOR DERMATOLOGYMeditec of America·Product code GEX·1987-10-01
K872732 — MCCUTCHEN ACETABULAR CUP PROSTHESISDow Corning Wright·Product code JDI·1987-10-01
K872753 — MYOSTIM(TM), MODEL 6600Medical Devices, Inc.·Product code IPF·1987-10-01
K872985 — SAMUELSON ACETABULAR CUPProtek, Inc.·Product code KWA·1987-10-01
K873073 — KIRSCHNER NEER-III PROXIMAL HUMERUSKirschner Medical Corp.·Product code HSD·1987-10-01
K873742 — HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESESHood Laboratories·Product code NWA·1987-10-01
K870794 — MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDERNihon Kohden America, Inc.·Product code GWL·1987-09-30
K871727 — MODIFIED RADIUS - MODEL NUMBER MM 5000Ultrasonix, Inc.·Product code JOP·1987-09-30
K872043 — CHURCHILL INTER-CARDIAC SUCKERChurchill Corp.·Product code DWF·1987-09-30
K872068 — HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEADAdvanced Technology Laboratories, Inc.·Product code DPW·1987-09-30
K872166 — FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KITBd Becton Dickinson Vacutainer Systems Preanalytic·Product code GKL·1987-09-30
K872241 — LIFESCOPE 12, BSM 8500A PATIENT MONITORNihon Kohden America, Inc.·Product code DSI·1987-09-30
K872346 — SURE-STREP A TEST KIT CATALOG NO. MB-1083Medix Biotech, Inc.·Product code GTZ·1987-09-30
K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30American Edwards Laboratories·Product code DRS·1987-09-30
K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEMTravenol Laboratories, S.A.·Product code FKX·1987-09-30
K872719 — EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTERShiley, Inc.·Product code DTN·1987-09-30
K873157 — OXFORD RETRO-ILLUMINATION CATARACT CAMERAHolofax , Ltd.·Product code HKI·1987-09-30
K873178 — URETERAL BULB DILATORSPenn Medical Devices, Inc.·Product code EZN·1987-09-30
K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLERespiratory Support Products, Inc.·Product code DTW·1987-09-30
K873394 — OVAL PULL-APART SHEATH/DILATORQuinton, Inc.·Product code DYB·1987-09-30
K873591 — A.R.M. (ASPEN RETURN MONITOR)Qmed, Inc.·Product code GEI·1987-09-30
K873608 — TENS LEADDesco Industries, Inc.·Product code GZI·1987-09-30
K873685 — NONPRESCRIPTION SUNGLASSESArcotoys, Inc.·Product code HQY·1987-09-30
K873744 — LEUKOCLIP(R)Beiersdorf, Inc.·Product code FZQ·1987-09-30
K870967 — ADMS TRANSRECTAL 7.5 MHZ PROBEDiasonics, Inc.·Product code ITX·1987-09-29
K871180 — ARTHRO AUTOMAT 5002F.M. Wiest USA, Inc.·Product code HRX·1987-09-29
K871181 — ARTHROCOMBI 5003F.M. Wiest USA, Inc.·Product code HRX·1987-09-29
K871759 — G-GT STANDARD CALIBRATORWako Chemicals USA, Inc.·Product code JIT·1987-09-29
K872836 — SPINOSCOPEDiagnospine Fabrication, Inc.·Product code IKN·1987-09-29
K872852 — EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTSandare Chemical Co., Inc.·Product code LCP·1987-09-29
K872961 — QTEST STREPQuidel Corp.·Product code GTZ·1987-09-29
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYAmerican Dade·Product code JHX·1987-09-29
K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHASerono Diagnostics, Inc.·Product code CEP·1987-09-29
K873210 — TELSTAR MODEL PPTelstar Electronics, Inc.·Product code ESD·1987-09-29
K873318 — SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PLLakewood Biochemical Co., Inc.·Product code JSJ·1987-09-29
K873319 — SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATELakewood Biochemical Co., Inc.·Product code JSJ·1987-09-29
K873320 — SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLDLakewood Biochemical Co., Inc.·Product code KZI·1987-09-29
K873321 — SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300Lakewood Biochemical Co., Inc.·Product code KZI·1987-09-29
K873322 — SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088Lakewood Biochemical Co., Inc.·Product code JSJ·1987-09-29
K873350 — EASY-TEST EMIT PROCAINAMIDE (PROC) #16648Em Diagnostic Systems, Inc.·Product code LAR·1987-09-29
K873354 — QBC VENOUS BLOOD CONTROL/MULTIPLER&D Systems, Inc.·Product code JPK·1987-09-29
K873467 — QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLQuantimetrix Medical Industries·Product code DIF·1987-09-29
K873468 — CUSTOM IN-THE-EAR HEARING AID SERIES MCA20Maico Hearing Instruments, Inc.·Product code ESD·1987-09-29
K873515 — UTERINE INJECTOR 2MMZinnanti Surgical Instruments, Inc.·Product code HES·1987-09-29
K873548 — OPTI-ZYME(R)Alcon Laboratories·Product code LPN·1987-09-29
K873560 — U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AIDRichards Medical Co., Inc.·Product code ESD·1987-09-29
K873594 — TIF FECAL TESTDevetec, Inc.·Product code LEA·1987-09-29
K873638 — MICRO-CHEM ANALYZEROcean Scientific, Inc.·Product code JJQ·1987-09-29
K873678 — SPECTROPHOTOMETER (MICROASSAY PLATE READERS)Slt Labinstruments, Inc.·Product code JJQ·1987-09-29
K873681 — ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95Em Diagnostic Systems, Inc.·Product code CJE·1987-09-29
K863155 — UNIVERSAL JET VENTILATOR MODEL AMS-1000Acutronic Medical Systems AG·Product code CBK·1987-09-28
K871416 — AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCERAcuson Computed Sonography·Product code JOP·1987-09-28
K871506 — ACUSON L538 TRANSDUCERAcuson Computed Sonography·Product code JOP·1987-09-28
K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PCHolter-Hausner Intl.·Product code HXA·1987-09-28
K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DCHolter-Hausner Intl.·Product code HXA·1987-09-28
K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BCHolter-Hausner Intl.·Product code HXA·1987-09-28
K872711 — MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERYDirected Energy, Inc.·Product code GEX·1987-09-28
K872849 — SPERM-SELECT ADDITIONAL INDICATIONPharmacia, Inc.·Product code HDR·1987-09-28
K873043 — MOUTH TO FACE RESUSCITATORArtec Environmental Monitoring Division·Product code BTM·1987-09-28
K873691 — CEDAR(TM) RETRACTOR RINGCedar Surgical, Inc.·Product code GZT·1987-09-28
K862970 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500Medtronic Vascular·Product code LDF·1987-09-25

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