FDA 510(k) clearances — page 1383

176,637 clearances on record, most recent first.

Clearances — page 1383

138,201–138,300 of 176,637

K874752 — GAMOW HYPERBARIC BAGHyperbaric Aerobics, Ltd.·Product code CBF·1988-02-02
K874757 — STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, IIIBaxter Healthcare Corp·Product code DIF·1988-02-02
K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERBentley Laboratories, Inc.·Product code DTZ·1988-02-02
K874867 — CATR(TM)-H CARDIOTOMY HOLDERBentley Laboratories, Inc.·Product code KPI·1988-02-02
K874896 — SARNS VISIFLOW AORTIC ARCH CANNULA3M Health Care, Sarns·Product code DWF·1988-02-02
K874939 — SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATEDKirschner Medical Corp.·Product code DXQ·1988-02-02
K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULASSolway, Inc.·Product code HAO·1988-02-02
K875104 — SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USELaserguide·Product code LLO·1988-02-02
K875176 — WAKO(TM) UIBCWako Chemicals USA, Inc.·Product code JQF·1988-02-02
K875206 — LACTATE DEHYDROGENASE CAT. # 320-68, 320-69Diagnostic Chemicals, Ltd. (Usa)·Product code CFJ·1988-02-02
K875210 — ALKALINE PHOSPHATASE CAT. # 306-22, 306-23Diagnostic Chemicals, Ltd. (Usa)·Product code CJE·1988-02-02
K875262 — V-TREND BETA-HCG DRY-SPOT TESTTexas Immunology, Inc.·Product code JHJ·1988-02-02
K875288 — BIOTROL CALIBRANT LEVEL 1Biotrol, USA, Inc.·Product code JIX·1988-02-02
K875318 — BIOTROL CALIBRANT LEVEL 3Biotrol, USA, Inc.·Product code JIX·1988-02-02
K870815 — KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265Kontron Instruments, Inc.·Product code GWQ·1988-02-01
K873566 — ELECTROSTIM I.F.Promatek Industries, Ltd.·Product code LIH·1988-02-01
K875209 — ACID PHOSPHATASE (KINETIC) CAT. # 320-06Diagnostic Chemicals, Ltd. (Usa)·Product code CKB·1988-02-01
K875320 — BIOTROL URIC ACID ENZYMATIQUE UV H.P.Biotrol, USA, Inc.·Product code CDO·1988-02-01
K875341 — EDEC 60 R/FElectromed Intl., Ltd.·Product code IZO·1988-02-01
K873533 — SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWAREMedical Electronics Laboratories, Inc.·Product code DSI·1988-01-29
K873546 — VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEMReimers Engineering, Inc.·Product code DWJ·1988-01-29
K873954 — NAMIC HAWKINS UNIVERSAL DRAINAGE SETNorth American Instrument Corp.·Product code FGE·1988-01-29
K874020 — ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICEAbbott Laboratories·Product code KPF·1988-01-29
K874037 — ANGIO WASTE FLUIDS DUMP BAGProcedure Products, Inc.·Product code DQO·1988-01-29
K874183 — ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEADDaig Corp.·Product code DTB·1988-01-29
K874307 — MODEL DMC-75 MINI-CATHETER SETLife-Tech Intl., Inc.·Product code FPA·1988-01-29
K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEMallinckrodt Critical Care·Product code FLL·1988-01-29
K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORMon-A-Therm, Inc.·Product code BZW·1988-01-29
K874522 — MODIFIED MYOCARDIAL TEMPERATURE SENSORMon-A-Therm, Inc.·Product code KRB·1988-01-29
K874549 — NEPHROSS I.Q. ANDANTEOrganon Teknika Corp.·Product code FJI·1988-01-29
K874555 — KEELER ACU 22XT OPHTHALMIC CRYO UNITKeeler Instruments, Inc.·Product code HPS·1988-01-29
K874571 — PATIENTWATCH (TM)Advanced Medical Technology, Inc.·Product code DSH·1988-01-29
K874599 — MOORE HIP PROSTHESIS SOLID STEMOrthopedic Systems, Inc.·Product code JDI·1988-01-29
K874616 — MOORE HIP PROSTHESIS FENESTRATED STEMOrthopedic Systems, Inc.·Product code JDI·1988-01-29
K874695 — HEALTHDYNE APNEA/HEART MONITOR, MODEL 900Healthdyne, Inc.·Product code DRT·1988-01-29
K874728 — CAPILLARY FLOW DIALYZERSBaxter Healthcare Corp·Product code FJI·1988-01-29
K874779 — BIPOLATOR 50Treace Medical, Inc.·Product code GEI·1988-01-29
K874813 — OMED WOUND CLOSURE STRIPSOxboro Medical Intl., Inc.·Product code FPX·1988-01-29
K874901 — REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLEFischer Imaging Corp.·Product code JAA·1988-01-29
K874927 — PTI HEART-CHILL(TM) CARDIAC INSULATING JACKETPioneering Technologies, Inc.·Product code DWC·1988-01-29
K875066 — ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KITDexall Biomedical Labs, Inc.·Product code DHB·1988-01-29
K875184 — UNICATH LABXre Corp.·Product code IZI·1988-01-29
K875292 — MICRODISCECTOMY CURETTE SETT. Korossurgical Instruments Corp.·Product code FZS·1988-01-29
K875342 — EDEC 90CElectromed Intl., Ltd.·Product code IZO·1988-01-29
K880028 — OMED DISPOSABLE SCALPELOxboro Medical Intl., Inc.·Product code GDX·1988-01-29
K880093 — CARETEX SKID RESISTANT SHOE COVERSJames River Corp.·Product code FXP·1988-01-29
K864946 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USEBio Quantum Technologies, Inc.·Product code HHR·1988-01-28
K872866 — STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)Labeltape Meditect, Inc.·Product code DRX·1988-01-28
K873115 — CABOT FIBER LASER PROBECabot Medical Corp.·Product code HET·1988-01-28
K874179 — BIOTIS (TM) SABHI (DOUBLE POUR)Otisville Biopharm, Inc.·Product code KZI·1988-01-28
K874204 — 450SLL DEFIBRILLATORMedical Research Laboratories, Inc.·Product code LDD·1988-01-28
K874421 — PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941AHewlett-Packard Co.·Product code DRX·1988-01-28
K874422 — PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942DHewlett-Packard Co.·Product code DRX·1988-01-28
K874423 — PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493EHewlett-Packard Co.·Product code DRX·1988-01-28
K874424 — PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489EHewlett-Packard Co.·Product code DRX·1988-01-28
K874469 — TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)Axelgaard Mfg. Co., Ltd.·Product code GXY·1988-01-28
K874471 — SUPER FLOSSERU.S. Pacific Corp.·Product code JES·1988-01-28
K874556 — BISCO PIT AND FISSURE SEALANTBisco, Inc.·Product code EBC·1988-01-28
K874557 — BISCO PORCELAIN REPAIR KITBisco, Inc.·Product code EBC·1988-01-28
K874562 — SECURATRODEMeddev International Corp.·Product code DRX·1988-01-28
K874884 — MEDTRONIC(R) ORTHOFLEX(TM)Metronic, Inc.·Product code BXB·1988-01-28
K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERYSolway, Inc.·Product code GZT·1988-01-28
K875015 — TRACETS 3000Lectec Corp.·Product code DRX·1988-01-28
K875018 — GHAJAR GUIDE TWIST DRILLNeurodynamics, Inc.·Product code HBG·1988-01-28
K875041 — FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODELabeltape Meditect, Inc.·Product code DRX·1988-01-28
K875054 — ACROMED ADS BONE NAIL DRIVERBuckman Co., Inc.·Product code HWR·1988-01-28
K875224 — HUDSON CRANINAL BURRSTri-Med, Inc.·Product code HBE·1988-01-28
K875284 — MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODEMedtronic Vascular·Product code GXY·1988-01-28
K871850 — TELEFLEX STEERABLE GUIDEWIRETeleflexmedical, Inc.·Product code DQX·1988-01-27
K872178 — MODIFICATION TO ARKIVE(TM)Diatek, Inc.·Product code BSZ·1988-01-27
K873602 — INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEMIntermedics Orthopedics·Product code JWH·1988-01-27
K873695 — MODEL 1859 TUMI/PRESSURE MODULELife-Tech Intl., Inc.·Product code EXY·1988-01-27
K873726 — ACID PHOSPHATASE TESTKing Diagnostics, Inc.·Product code CKE·1988-01-27
K874093 — SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUPProtek, Inc.·Product code JDI·1988-01-27
K874160 — ZEISS 40 SL/P PHOTO SLIT LAMPCarl Zeiss, Inc.·Product code HJO·1988-01-27
K874203 — AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800Amersham Corp.·Product code DBF·1988-01-27
K874252 — KREDA DISCRichmond Products, Inc.·Product code HOQ·1988-01-27
K874320 — CELLECT LABTRAK SOFTWAREInstrumentation Laboratory CO·Product code GKL·1988-01-27
K874354 — AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020Madsen Electronics (Canada) , Ltd.·Product code ETY·1988-01-27
K874411 — DONALDSON NATURAL EYEPATCH 'PATIENT PAK'Keeler Instruments, Inc.·Product code HMP·1988-01-27
K874447 — DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELECMedac, Inc.·Product code DRO·1988-01-27
K874512 — MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEMStackhouse Assoc.·Product code FYD·1988-01-27
K874530 — URETHRAL DILATOR ENDOSCOPEAdvanced Surgical Intervention, Inc.·Product code KOB·1988-01-27
K874607 — FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMSOrganon Teknika Corp.·Product code LKN·1988-01-27
K874644 — STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACONPharmetics, Inc.·Product code FLE·1988-01-27
K874682 — MMG CATHETER PLUG W/DRAINAGE TUBE COVERMedical Marketing Group·Product code KOD·1988-01-27
K874964 — DENTAL HAND INSTRUMENTSSolway, Inc.·Product code EKJ·1988-01-27
K875147 — TORQUE HEX WRENCHCardiac Pacemakers, Inc.·Product code DTF·1988-01-27
K875162 — ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSHOrtho Diagnostic Systems, Inc.·Product code HHT·1988-01-27
K875259 — BITEK(TM) BLOOD CULTURE SYSTEMDefinitive Diagnostics, Inc.·Product code JSG·1988-01-27
K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMERSterling Drug, Inc.·Product code JTQ·1988-01-27
K875305 — MODEL UCA / SPEC SYSTEM UCASpec Systems, Inc.·Product code FZH·1988-01-27
K875321 — MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSEKinetic Concepts, Inc.·Product code IOQ·1988-01-27
K875362 — BREWER GEL FOR ANAEROBESFairleigh Dickinson Laboratories, Inc.·Product code KZJ·1988-01-27
K880083 — GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERSGambro, Inc.·Product code FJI·1988-01-27
K874355 — OPACITY LENSMETER 701Intraoptics, Inc.·Product code HKI·1988-01-26
K874868 — OPTI-FIX COLLARED FEMORAL COMPONENTSRichards Medical Co., Inc.·Product code JDG·1988-01-26
K875067 — GOOD LOOKS DAZZLERSMel Appel·Product code HQY·1988-01-26
K864841 — WATER-JEL(R) BURN DRESSINGTrilling Resources, Ltd.·Product code FRO·1988-01-22
K870424 — LSP AUTOMATIC VENTILATOR, MODEL 456Life Support Products, Inc.·Product code BTL·1988-01-22

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