FDA 510(k) clearances — page 1353

176,637 clearances on record, most recent first.

Clearances — page 1353

135,201–135,300 of 176,637

K882925 — ACS SCHWARTEN XT BALLOON DILATATION CATHETERAdvanced Cardiovascular Systems, Inc.·Product code LIT·1988-09-28
K883000 — ACS ANGIOSCOPE GUIDE WIREAdvanced Cardiovascular Systems, Inc.·Product code LYK·1988-09-28
K883089 — 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02Heraeus Lasersonics, Inc.·Product code GEX·1988-09-28
K883149 — TEN20 CONDUCTIVEWeaver & Co.·Product code GYB·1988-09-28
K883345 — SARNS INFANT VENOUS RESERVOIR MODEL #163873M Health Care, Sarns·Product code DTN·1988-09-28
K883376 — STERILIZATION WRAP TYPE 22,44,77East Texas Lighthouse For the Blind·Product code FRG·1988-09-28
K883429 — LINDSTROM CORDLESS EPILATORA Place of Health & Beauty·Product code KCW·1988-09-28
K883684 — HERPES VIRUS CONTROL SLIDESVal Tech Diagnostics, Inc.·Product code GQN·1988-09-28
K883685 — IMMUNO/FEBRILE ANTIGENSImmunostics Co., Inc.·Product code GNC·1988-09-28
K883744 — MANAN HUBER STYLE INFUSION NEEDLEManan Medical Products, Inc.·Product code FMF·1988-09-28
K883760 — STORZ MODEL 62 ENT CAMERA SYSTEMStorz Instrument Co.·Product code FWL·1988-09-28
K883943 — CCM-1 VIDEO CAMERA SYSTEMMedical Concepts, Inc.·Product code FTS·1988-09-28
K883944 — MEC-1 VIDEO COMBO SYSTEMMedical Concepts, Inc.·Product code FTS·1988-09-28
K883952 — U. V. SUNLAMP 95UF-11Light Sources, Inc.·Product code FTC·1988-09-28
K875108 — ACS CORONARY ANGIOSCOPIC CATHETERAdvanced Cardiovascular Systems, Inc.·Product code LYK·1988-09-27
K880756 — MODEL PM-20A PHYSIOLOGICAL MONITORAdvanced Medical Systems, Inc.·Product code DQA·1988-09-27
K880920 — LASER FLARE CELL METER FC-1000Kowa Optimed, Inc.·Product code HJO·1988-09-27
K882568 — 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYSpembly Medical , Ltd.·Product code GEH·1988-09-27
K882771 — EXTRACORPOREAL MEMBRANE OXYGENATION CATHETERCook, Inc.·Product code DWF·1988-09-27
K882809 — THYMAPADSomatics, Inc.·Product code GXY·1988-09-27
K882892 — MEMBRANE OXYGENATORBaxter Bentley Laboratories, Inc.·Product code DTZ·1988-09-27
K882928 — TAD INTERMEDIATE & TAD STANDARD GUIDE WIREAdvanced Cardiovascular Systems, Inc.·Product code DQX·1988-09-27
K882981 — PTI INTRA-ART CORONARY ARTERY RETRACTION CLIPPioneering Technologies, Inc.·Product code DWS·1988-09-27
K883320 — MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBESherwood Medical Co.·Product code JKA·1988-09-27
K883360 — HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOMHologic, Inc.·Product code KGI·1988-09-27
K883551 — SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-27
K883563 — SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPSSharplan Lasers, Inc.·Product code GEX·1988-09-27
K883762 — BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODEBard Electro Medical Systems, Inc.·Product code GEI·1988-09-27
K880416 — WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEMWallach Surgical Devices, Inc.·Product code GEH·1988-09-26
K881402 — 629V SPIROMETER, PULMONARY FUNCTION ANALYZERAmerican Electromedics Corp.·Product code BZG·1988-09-26
K881416 — MYOTRACThought Technology , Ltd.·Product code HCC·1988-09-26
K881632 — FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENTHuntleigh Technology, Inc.·Product code JOW·1988-09-26
K881851 — VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METERMicro Medical, Ltd.·Product code DSB·1988-09-26
K882315 — VIR-A-VAC EMPTYViratec Corp.·Product code GAZ·1988-09-26
K882441 — SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATIONSurgical Laser Technologies, Inc.·Product code HQB·1988-09-26
K882969 — VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORTGish Biomedical, Inc.·Product code DQY·1988-09-26
K883053 — SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2AScimed Life Systems, Inc.·Product code DTZ·1988-09-26
K883054 — SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & IIScimed Life Systems, Inc.·Product code DTZ·1988-09-26
K883135 — PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)Pioneering Technologies, Inc.·Product code DWS·1988-09-26
K883201 — VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYSVital Metrics, Inc.·Product code HBI·1988-09-26
K883330 — BASIC HEATER-COOLER UNIT, 115/100V 16-02-20Shiley, Inc.·Product code DTR·1988-09-26
K883331 — BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10Shiley, Inc.·Product code DTR·1988-09-26
K883332 — MAST FOR BASIC HEATER-COOLER UNIT 16-09-00Shiley, Inc.·Product code DTR·1988-09-26
K883346 — SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13FDevices For Vascular Intervention, Inc.·Product code LIT·1988-09-26
K883548 — SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-26
K883549 — SCEPTOR STREPTOCOCCUS MIC PANEL #80322Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-26
K883550 — SCEPTOR STAPHYLOCOCCUS MIC #80324Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-26
K883552 — SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-26
K883553 — SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-26
K883554 — SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-26
K883555 — SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332Bd Becton Dickinson Vacutainer Systems Preanalytic·Product code JWY·1988-09-26
K883821 — FEF(TM) END-TIDAL CO2 DETECTORFenem, Inc.·Product code CCK·1988-09-26
K874688 — FLOWTRON AC200/2Huntleigh Technology, Inc.·Product code IRP·1988-09-23
K880474 — AREA (DENTAL CHAIR)Alpine Dental Equipment Co.·Product code KLC·1988-09-23
K880475 — SKEMA (DENTAL UNIT)Alpine Dental Equipment Co.·Product code KLC·1988-09-23
K882167 — IVY COMMANDER, MODEL 600Ivy Medical, Inc.·Product code LDR·1988-09-23
K882310 — DUAL-TEMP(TM) COOLING/WARMING UNITSeabrook Medical Systems, Inc.·Product code ILO·1988-09-23
K882427 — CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066Ela Medical, Inc.·Product code DXY·1988-09-23
K882800 — COLTENE PRESIDENT JET REGULAR BODYColtene, Inc.·Product code ELW·1988-09-23
K882871 — CASF DRILL GUIDE DG 170Terray Manufacturing, Inc.·Product code LYQ·1988-09-23
K883638 — SAFESITE INJECTION SITE AND BLUNT CANNULABaxter Healthcare Corp·Product code FPA·1988-09-23
K883686 — STERILE EMPTY GLASS VIALSFarris Laboratories, Inc.·Product code LDH·1988-09-23
K875072 — MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEMAmana Medical Group·Product code GZJ·1988-09-22
K881341 — NOVA LITE(TM) SAInova Diagnostics, Inc.·Product code LLL·1988-09-22
K882094 — GARDS DEODORANT SANITARY NAPKINHospital Specialty Co.·Product code HHL·1988-09-22
K882231 — SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)Philips Medical Systems, Inc.·Product code IYE·1988-09-22
K882525 — SPINAL MICROKNIFEKarlin Technology, Inc.·Product code HTS·1988-09-22
K882631 — EMPI MODEL 727,NMSEmpi·Product code GZJ·1988-09-22
K882678 — ITE HEARING AID, SIEMENS MODEL 007, WITH TELOSSiemens Hearing Instruments, Inc.·Product code ESD·1988-09-22
K882740 — ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAYLipogen, Inc.·Product code LKJ·1988-09-22
K882907 — AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KITAmersham Corp.·Product code JLW·1988-09-22
K882922 — TECHMEDICA MP SYSTEMTechmedica, Inc.·Product code KTT·1988-09-22
K883001 — QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code CZJ·1988-09-22
K883002 — QM300 PREALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code JZJ·1988-09-22
K883103 — EPICARDIA PC/FCMedicomp, Inc.·Product code DSI·1988-09-22
K883179 — HIP FRACTURE STEM SYSTEMHowmedica Corp.·Product code KWL·1988-09-22
K883240 — AVL MODEL 986 ELECTROLYTE ANALYZERAvl Scientific Corp.·Product code CEM·1988-09-22
K883308 — PARKER BATHING SYSTEMMid-Canada Medical·Product code ILJ·1988-09-22
K883316 — QUIDEL PREGNANCY TEST CONTROLQuidel Corp.·Product code JJX·1988-09-22
K883378 — VISTA MR 2055 HP SYSTEMPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1988-09-22
K883492 — TECHNICON DPA-1 IMMUNOGLOBULIN ATechnicon Instruments Corp.·Product code CZP·1988-09-22
K883493 — TECHNICON DPA-1 IMMUNOGLOBULIN MTechnicon Instruments Corp.·Product code DFL·1988-09-22
K883508 — HERA HDegussa Dental, Inc.·Product code EJT·1988-09-22
K883509 — HERAEUS DG 63Degussa Dental, Inc.·Product code EJS·1988-09-22
K883515 — DU PONT DIMENSION C-REACTIVE PROTEIN METHODE.I. Dupont DE Nemours & Co., Inc.·Product code DCN·1988-09-22
K883518 — EVENT MARKER & A SECOND PRESSURE TREND OUTPUTMetatech Corp.·Product code GWM·1988-09-22
K883588 — COMPEED ATHLETIC DRESSINGColoplast A/S·Product code FRO·1988-09-22
K883616 — SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)Diagnostic Products Corp.·Product code DHB·1988-09-22
K883711 — QM300 CALIBRATOR F PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DFC·1988-09-22
K883712 — QM300 CONTROL F PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DFC·1988-09-22
K883715 — AXIAL COMPRESSION SCREWStraub Clinic and Hospital·Product code KTT·1988-09-22
K882009 — KING KONDOM (CONDOM)King Kondom Products, Inc.·Product code HIS·1988-09-21
K882018 — MEDACORD PVL, PERSONAL VASCULAR LABORATORYMedasonics, Inc.·Product code JAF·1988-09-21
K882867 — CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBECorpak Co.·Product code KNT·1988-09-21
K881488 — HOLTER SCANNERCardiodata Corp.·Product code DSI·1988-09-20
K882592 — HEART HUGGER STERNUM SUPPORT HARNESSGeneral Cardiac Technology, Inc.·Product code KMO·1988-09-20
K882594 — THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEMOmni-Flow, Inc.·Product code FRN·1988-09-20
K882654 — PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.Surgical Innovators of America, Inc.·Product code GEY·1988-09-20
K882683 — JOBST EXTREMITY PUMP(R) SYSTEM 7500Jobst Institute, Inc.·Product code JOW·1988-09-20
K882761 — TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)Intramed Laboratories, Inc.·Product code HIH·1988-09-20

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