FDA 510(k) clearances — page 1351

176,637 clearances on record, most recent first.

Clearances — page 1351

135,001–135,100 of 176,637

K882758 — CENTRIFUGAL PUMP SYSTEM LX/DX VERSION3M Health Care, Sarns·Product code KFM·1988-10-13
K882934 — CASF CANCELLOUS BONE SCREW, BT650Terray Manufacturing, Inc.·Product code HWC·1988-10-13
K883065 — ALLOPREP SYSTEMOsteotech, Inc.·Product code KIT·1988-10-13
K883082 — PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEMDeknatel, Inc.·Product code CAC·1988-10-13
K883092 — BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOURBennett X-Ray Corp.·Product code IZL·1988-10-13
K883152 — EP-STATCoherent Systems, Inc.·Product code DQK·1988-10-13
K883221 — PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KITPioneering Technologies, Inc.·Product code DWF·1988-10-13
K883270 — IRIS ND:YAG OPTHALMIC LASERCalifornia Laboratories, Inc.·Product code LQJ·1988-10-13
K883296 — LARYNGOSCOPELothar Scharras·Product code CCW·1988-10-13
K883326 — TECHNICON RA(TM) SYSTEMS - MAGNESIUMTechnicon Instruments Corp.·Product code JGJ·1988-10-13
K883358 — TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CMTelescan Medical Systems·Product code DXH·1988-10-13
K883361 — ARTHRO-TRAC(TM)Rudolph Beaver, Inc.·Product code HRX·1988-10-13
K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)Tech-Co, Inc.·Product code CKD·1988-10-13
K883435 — NOVASPEC II SPECTROPHOTOMETERPharmacia, Inc.·Product code JJQ·1988-10-13
K883439 — INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEMMedtronic Blood Systems, Inc.·Product code DTR·1988-10-13
K883654 — STERI-TAG(TM) STERILE LABEL SETSAcacia Laboratories, Inc.·Product code LYV·1988-10-13
K883659 — HLE-1000 HIGH/LOW TREATMENT TABLERich-Mar Corp.·Product code INQ·1988-10-13
K883737 — VFQ HEAD COILResonex, Inc.·Product code LNH·1988-10-13
K883824 — STERILE SURGICAL LATEX GLOVESIntl. Trading Ventures, Inc.·Product code KGO·1988-10-13
K883861 — DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TESTCasco Standards·Product code JJY·1988-10-13
K883921 — OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATINGOsteonics Corp.·Product code LWJ·1988-10-13
K883927 — CIBA CORNING MAGIC LITE HCG IMMUNOASSAYCiba Corning Diagnostics Corp.·Product code JHI·1988-10-13
K883946 — VISION CREATINE KINASEAbbott Laboratories·Product code CGS·1988-10-13
K884019 — ALM OPERATING TABLESAlm Surgical Equipment, Inc.·Product code FWX·1988-10-13
K884032 — MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORMorgan Associates, Inc.·Product code GZJ·1988-10-13
K884039 — MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940Medical Dynamics, Inc.·Product code FWH·1988-10-13
K884055 — SURGI-TAG(TM) STERILE LABEL SETSAcacia Laboratories, Inc.·Product code LYV·1988-10-13
K884073 — LARYNGOSCOPE BLADE (ROBERTSHAW STYLE)Eastmed Enterprises, Inc.·Product code CCW·1988-10-13
K884092 — SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80Surgilase, Inc.·Product code GEX·1988-10-13
K884110 — LTDT PATIENT LIFTERDevine Medical Products·Product code ILK·1988-10-13
K884112 — CARETEX OR TOWELJames River Corp.·Product code KKX·1988-10-13
K874923 — PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATEHowmedica Corp.·Product code JWH·1988-10-12
K881008 — MAXERECTKenneth Chapman·Product code LKY·1988-10-12
K881259 — MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAILTriton Biosciences, Inc.·Product code LYE·1988-10-12
K881481 — DIGITRON STENOSIS PROTOCOLSiemens Gammasonics, Inc.·Product code LLZ·1988-10-12
K882478 — 100-01778-52 ULTRASOUND SYSTEMDiasonics, Inc.·Product code IYO·1988-10-12
K882551 — AMBULATORY PH DATA RECORDER SYSTEM, APH-2000Intl. Biomedics, Inc.·Product code KLA·1988-10-12
K882571 — KOLYNOS DENTAL FLOSSWhitehall Laboratories, Inc.·Product code JES·1988-10-12
K882895 — MODIFIED BETA QUIK STAT EIA KITPacific Biotech, Inc.·Product code DHA·1988-10-12
K882953 — HYDRAMED BY LECHLERLechler, Inc.·Product code CAF·1988-10-12
K883183 — TRACER BONE MILLDe Medica Mfg., Inc.·Product code LYS·1988-10-12
K883234 — TONOMITOR (TM) + SUMPTonometrics, Inc.·Product code FFT·1988-10-12
K883242 — EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO)Cancer Technologies, Inc.·Product code FMF·1988-10-12
K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KITHospal Medical Corp.·Product code KDI·1988-10-12
K883416 — MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)Scott All-Sports, Inc.·Product code JXL·1988-10-12
K883437 — DENTAL CHAIRE.F. Brewer Co.·Product code KLC·1988-10-12
K883465 — ORTHO-SEALBisco, Inc.·Product code DYH·1988-10-12
K883610 — LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, Inc.·Product code FCN·1988-10-12
K883736 — STERILE SURGEONS GLOVESMedical Manufacturers Marketing Co.·Product code KGO·1988-10-12
K883758 — ALBABOND 60Degussa Dental, Inc.·Product code EJT·1988-10-12
K883792 — TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTSCatachem, Inc.·Product code JIY·1988-10-12
K883798 — SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANELBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-10-12
K883800 — SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANELBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-10-12
K883910 — ACUFEX INTERFERENCE SCREW AND SCREWDRIVERAcufex Microsurgical, Inc.·Product code HWC·1988-10-12
K883989 — KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.·Product code GIF·1988-10-12
K883990 — KVM ISOTONIC DILUENTKvm Technologies, Inc.·Product code GIF·1988-10-12
K883991 — KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.·Product code GGK·1988-10-12
K883992 — KVM PREPACK HEMATOLOGY REAGENT SETKvm Technologies, Inc.·Product code GKK·1988-10-12
K883995 — X-ACT UREA/TDAPro-Lab, Inc.·Product code JSE·1988-10-12
K883996 — X-ACT LDC/INDPro-Lab, Inc.·Product code JSE·1988-10-12
K883999 — QUIDEL GROUP A STREP TESTQuidel Corp.·Product code GTZ·1988-10-12
K880439 — PROTECT-AIDS UNDERGLOVEMedical Armor Corp.·Product code LYU·1988-10-11
K880440 — PROTECT-AIDS AUTOPSY UNDERGLOVEMedical Armor Corp.·Product code LYU·1988-10-11
K882378 — P-7 COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems (Cleveland), Inc.·Product code JAK·1988-10-11
K882736 — AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERAAmersham Corp.·Product code JJY·1988-10-11
K883264 — SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25Philips Medical Systems, Inc.·Product code IYE·1988-10-11
K883460 — FOCUS TOTAL HIP SYSTEMDepuy, Inc.·Product code JDI·1988-10-11
K883731 — TDX CANNABINOIDS-GSAbbott Laboratories·Product code LDJ·1988-10-11
K883920 — EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. ASyva Co.·Product code DLJ·1988-10-11
K884022 — EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINESyva Co.·Product code DKZ·1988-10-11
K884132 — TECNOL BUCKS TRACTION W/HEEL PROTECTORTechnol, Inc.·Product code KQZ·1988-10-11
K873674 — SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNERShimadzu Corp.·Product code JOP·1988-10-07
K881739 — LENZ CLENZERLens Care, Inc.·Product code LYL·1988-10-07
K882590 — VIADERMApplied Biomedical Sciences·Product code KGN·1988-10-07
K883101 — DVS (OPTION 01)O.M.I. Oncology Microsystems, Inc.·Product code IYE·1988-10-07
K883483 — AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATORAutoflow Products, Co.·Product code CAN·1988-10-07
K883516 — DIASONICS MT/P IMAGING SYSTEMDiasonics, Inc.·Product code LNH·1988-10-07
K883520 — 0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYSTPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1988-10-07
K883546 — TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCERAdvanced Technology Laboratories, Inc.·Product code IYO·1988-10-07
K883876 — WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLEE.G. Dick & Assoc.·Product code GDM·1988-10-07
K883963 — RANEY AND LEROY-RANEY SCALP CLIPNew England Surgical Instrument Corp.·Product code HBO·1988-10-07
K883988 — NON-REBREATHING TEE PIECE (NRTP)Dhd Medical Products Div. Diemolding Corp.·Product code CBP·1988-10-07
K884041 — MASTER-GUARDSparco, Inc.·Product code KCT·1988-10-07
K884042 — ROCKET CERVICAL SPATULAA & A Medical, Inc.·Product code HHT·1988-10-07
K884072 — 15 MILLIMETER MALE AND FEMALE ADAPTERSEastmed Enterprises, Inc.·Product code CAI·1988-10-07
K884076 — SUREBREATH DOMEIpax, Inc.·Product code GAD·1988-10-07
K880599 — POCKET MANOMETERAbbott Laboratories·Product code DXN·1988-10-06
K880674 — MICROMEDIC CRACKPOT RIA KITIcn Micromedic Systems·Product code KLN·1988-10-06
K881380 — B. FRAGTEXAmerican Biomedical Products, Inc.·Product code JSP·1988-10-06
K881983 — HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENTHowmedica Corp.·Product code LWJ·1988-10-06
K882199 — CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TESTAuspharm Intl. , Ltd.·Product code LYR·1988-10-06
K882327 — PACER SENSING ANALYZER (PSA 100)Oscor Medical Corp.·Product code DTC·1988-10-06
K882380 — SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIRScimed Life Systems, Inc.·Product code DTN·1988-10-06
K882475 — AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200Amersham Corp.·Product code LFX·1988-10-06
K882588 — BLUE DOT(TM) TEST FOR PREGNANCYV-Tech, Inc.·Product code LCX·1988-10-06
K882728 — AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190Amersham Corp.·Product code JJY·1988-10-06
K882756 — LANTOR CUBE STERILIZER TEST PACKLantor Group·Product code JOJ·1988-10-06
K883015 — POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIPCardiac Control Systems, Inc.·Product code DTB·1988-10-06
K883051 — USCI SOFT-TIP ANGIOGRAPHIC CATHETERC.R. Bard, Inc.·Product code DQO·1988-10-06
K883147 — TRACE ELEMENTS SERUM TOXICOLOGY CONTROLUtak Laboratories, Inc.·Product code JJY·1988-10-06

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