FDA 510(k) clearances — page 1369

176,637 clearances on record, most recent first.

Clearances — page 1369

136,801–136,900 of 176,637

K881698 — ATS PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.·Product code LDZ·1988-05-13
K881730 — BREAST LOCALIZATION NEEDLESHart Enterprises, Inc.·Product code GDM·1988-05-13
K881737 — AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AIDAudiotone, Inc.·Product code ESD·1988-05-13
K881738 — AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AIDAudiotone, Inc.·Product code ESD·1988-05-13
K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42Alpha-Tec Systems, Inc.·Product code JSK·1988-05-13
K881887 — SHARPLAN 719Y MICROSLAD(TM)Sharplan Lasers, Inc.·Product code GEX·1988-05-13
K880300 — CARDIOBEEPER(R) IIISurvival Technology, Inc.·Product code DXH·1988-05-12
K880754 — DRI-CLAVE LIQUID KLEENZALLColumbus Dental Mfg. Co.·Product code EHZ·1988-05-12
K880780 — HEARTSTART 2000 DEFIBRILLATOR TESTER, ECGFirst Medical Devices Corp.·Product code DRL·1988-05-12
K881004 — OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECRKeymed, Inc.·Product code FCX·1988-05-12
K874540 — MARSH ELDER ALLERGEN DISCIncstar Corp.·Product code DHB·1988-05-11
K874546 — SIM MODULECritikon Company, LLC·Product code FRN·1988-05-11
K874590 — INNOVATIVE IMPLANTS AND COVER SCREWSImplant Innovations International, Inc.·Product code DZE·1988-05-11
K874861 — ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.Acuson Computed Sonography·Product code DPT·1988-05-11
K874883 — WALNUT ALLERGEN DISCIncstar Corp.·Product code DHB·1988-05-11
K875251 — ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICEPhilips Medical Systems (Cleveland), Inc.·Product code IYO·1988-05-11
K875316 — BIONICA MDS 110 PCABionica, Inc.·Product code FRN·1988-05-11
K880168 — INCSTAR'S BIRCH ALLERGEN DISCIncstar Corp.·Product code DHB·1988-05-11
K880221 — INCSTAR'S PIGWEED ALLERGEN DISCIncstar Corp.·Product code DHB·1988-05-11
K880348 — PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI.J.F. Jelenko & Co., Inc.·Product code EJT·1988-05-11
K880589 — ROTA-DENT TOOTH CLEANERPro-Dentec·Product code JEQ·1988-05-11
K880663 — SHILEY BCD PLUS HEAT EXCHANGERShiley, Inc.·Product code DTR·1988-05-11
K880684 — XR PRIMERKerr Corporation (Danbury)·Product code KLE·1988-05-11
K880685 — PORCELITE DUAL CURE CEMENTKerr Corporation (Danbury)·Product code EMA·1988-05-11
K880693 — MEDSURG MYELOGRAM TRAYMedsurg Industries, Inc.·Product code FMF·1988-05-11
K880781 — DATALOGGER CHART RECORDERAir-Shields, Inc.·Product code DSF·1988-05-11
K880849 — EXAMIX DISPENSERG-C Intl. Corp.·Product code EKJ·1988-05-11
K880890 — THE S.A.F.E. SYSTEMPfizer Laser Systems·Product code FYD·1988-05-11
K880913 — M424 EMG MONITORBio-Logic Devices·Product code HCC·1988-05-11
K880914 — T824 TEMPERATURE MONITORBio-Logic Devices·Product code HCC·1988-05-11
K880916 — M444 EMG MONITORBio-Logic Devices·Product code HCC·1988-05-11
K880956 — SNOAR(TM) OPEN AIRWAY APPLIANCEKent J. Toone, D.D.S.·Product code LQZ·1988-05-11
K880993 — AMALGAMATORAcecodent, Inc.·Product code EFD·1988-05-11
K881211 — TRU-TECH 310 ULTRASOUND THERAPY UNIT #310Tru-Trac Therapy Products, Inc.·Product code IMI·1988-05-11
K881236 — TORAY ANTHRON P-U CATHETERSToray Industries (America), Inc.·Product code FOZ·1988-05-11
K881345 — IMX FERRITINAbbott Laboratories·Product code DGD·1988-05-11
K881652 — AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AIDAudiotone, Inc.·Product code ESD·1988-05-11
K881745 — INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETERShiley Infusaid, Inc.·Product code LJT·1988-05-11
K881848 — MODIFIED MODEL 2100 ND:YAG LASERSharplan Lasers, Inc.·Product code GEX·1988-05-11
K874917 — PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEMOxford Medilog, Inc.·Product code DXN·1988-05-10
K875068 — AIDS SAFETY BELTAids Safety Belt, Inc.·Product code HIS·1988-05-10
K880572 — OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOROhmeda Medical·Product code DXN·1988-05-10
K880831 — LARGE LUMEN Y ADAPTER W/ROTATING DEVICEInterventional Medical, Inc.·Product code DTL·1988-05-10
K880715 — (MB-650) BLOOD PRESSURE MONITORSharp Electronics Corp.·Product code DXN·1988-05-09
K880779 — MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAYMedsurg Industries, Inc.·Product code DWF·1988-05-09
K881618 — ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK3M Company·Product code FXX·1988-05-09
K874127 — ABBOTT TESTPACK RSVAbbott Laboratories·Product code GQG·1988-05-06
K874606 — CATHRA GRAM POSITIVE SCREENMct Medical, Inc.·Product code LQL·1988-05-06
K875159 — DETECTADOT SYSTEM 2000 CMV IGG TESTGull Laboratories, Inc.·Product code GQI·1988-05-06
K880196 — LAMINARIAMedgyn Products, Inc.·Product code HDY·1988-05-06
K880269 — LCS FEMORAL HIP PROSTHESISDepuy, Inc.·Product code JDI·1988-05-06
K880487 — NEOTECH MECONIUM ASPIRATOR (STERILE)Neotech Products, Inc.·Product code BTR·1988-05-06
K880554 — VSM(R) R2 PAPER CHART RECORDERPhysio-Control Corp.·Product code DSF·1988-05-06
K880595 — HORIZON 2000/S 266-XXX-XXXMennen Medical, Inc.·Product code DPS·1988-05-06
K880601 — WIRE PASS DRILL BITSNuell Air Equipment & Hospital Supplies, Inc.·Product code HBE·1988-05-06
K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)Fred Sammons, Inc.·Product code IRQ·1988-05-06
K880671 — MODIFIED INTERSEPT PEDIATRIC BLOOD FILTERMedtronic Blood Systems, Inc.·Product code DTM·1988-05-06
K880672 — SENTINEL PULSE OXIMETERSentinel Monitoring Technologies, Ltd.·Product code DQA·1988-05-06
K880698 — TITAN GEL-PC GLYCO-HEME(TM) SYSTEMHelena Laboratories·Product code LCP·1988-05-06
K880712 — CLP NORMAL COAGULATION CONTROLCreative Laboratory Products, Inc.·Product code GIZ·1988-05-06
K880821 — RESUBMITTED ABBOTT TESTPACK ROTAVIRUSAbbott Laboratories·Product code LIQ·1988-05-06
K880898 — MULTICOR AND PACEMAKERSTpl-Cordis, Inc.·Product code DXY·1988-05-06
K880903 — BARD (R) ESKA ERECTIOMETERC.R. Bard, Inc.·Product code LIL·1988-05-06
K881187 — NATELSON TUBES, HEPARIN AND PLAINHelps Products, Inc.·Product code GIO·1988-05-06
K881262 — CARAWAY TUBES, HEPARIN AND PLAINHelps Products, Inc.·Product code GIO·1988-05-06
K881510 — CLP ABNORMAL COAGULATION CONTROLCreative Laboratory Products, Inc.·Product code GGC·1988-05-06
K881666 — HR(TM) INTRAVASCULAR CATHETERIcu Medical, Inc.·Product code FOZ·1988-05-06
K880088 — CADWELL EXCELCadwell Laboratories, Inc.·Product code GWF·1988-05-04
K880519 — SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650Fischer Imaging Corp.·Product code IZO·1988-05-04
K880521 — SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650Fischer Imaging Corp.·Product code IZO·1988-05-04
K880522 — THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80Fischer Imaging Corp.·Product code IZO·1988-05-04
K880523 — THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75Fischer Imaging Corp.·Product code IZO·1988-05-04
K880524 — THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100Fischer Imaging Corp.·Product code IZO·1988-05-04
K880574 — MODIFIED IMIPENEM SUSCEPTIBILITY POWDERMerck, Sharp & Dohme·Product code JTT·1988-05-04
K880881 — ARTUS DISPOSABLE SHEATHS/CUTTERSAcufex Microsurgical, Inc.·Product code HSZ·1988-05-04
K881183 — VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4HCamino Laboratories, Inc.·Product code GWM·1988-05-04
K881276 — HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONSIme Co. , Ltd.·Product code KCW·1988-05-04
K881343 — DURADERM BUTTERFLYSentry Medical Products, Inc.·Product code GXY·1988-05-04
K881421 — DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOKShiley, Inc.·Product code CAC·1988-05-04
K881460 — SMOKEVAC ELECTORSURGICAL PENCILByron Medical·Product code GEI·1988-05-04
K881484 — BIOFRAGMENTABLE BOWEL ANASTOMOSIS RINGDavis & Geck, Inc.·Product code GDW·1988-05-04
K881598 — SDL TRICHROME STAINScientific Device Laboratory, Inc.·Product code JTS·1988-05-04
K881603 — ULTRA TRACTIONComponent Equipment Mfg., Inc.·Product code ITH·1988-05-04
K881704 — EASY TENSAmerican Imex·Product code GZJ·1988-05-04
K881762 — ROLLS 2000 SERIES WHEELCHAIRInvacare Corp.·Product code IOR·1988-05-04
K874569 — SUREDROP EYEDROP GUIDESuredrop, Inc.·Product code JYJ·1988-05-03
K874591 — ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, Co.·Product code HPX·1988-05-03
K875030 — OCU-1Rudolph Beaver, Inc.·Product code HMX·1988-05-03
K875381 — ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATERFord Laboratories, Inc.·Product code IMI·1988-05-03
K880345 — CYSTOTOMES/KNIFESMyocure, Inc.·Product code HNY·1988-05-03
K880346 — CANNULASMyocure, Inc.·Product code HMX·1988-05-03
K880347 — ANESTHESIA/RETROBULBAR NEEDLESMyocure, Inc.·Product code HMX·1988-05-03
K880490 — BLUE PLASTIC EYE SHIELDEye Garter Company, Inc.·Product code HOY·1988-05-03
K880771 — MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEMMedsurg Industries, Inc.·Product code DQR·1988-05-03
K880908 — MODEL PC ARGON LASERHgm, Inc.·Product code GEX·1988-05-03
K881219 — AUTOMATIC PERIMETER, AP-340Kowa Optimed, Inc.·Product code HPT·1988-05-03
K881744 — PORGES URETERAL STENTBivona Medical Technologies·Product code FAD·1988-05-03
K873012 — INFANT CANNULAGresco International, Inc.·Product code DQR·1988-05-02
K874363 — ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.Acuson Computed Sonography·Product code IYO·1988-05-02
K874558 — SL SERIES, SL 15, 18, 20 & 25Philips Medical Systems, Inc.·Product code IYE·1988-05-02

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