FDA 510(k) clearances — page 1304

176,637 clearances on record, most recent first.

Clearances — page 1304

130,301–130,400 of 176,637

K894340 — PCI MODEL 2041-A TELEMETRY MONITORAccucore, Inc.·Product code DXH·1989-10-02
K894445 — MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDEMallinckroot, Inc.·Product code DYB·1989-10-02
K894460 — SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIASiemens Medical Electronics·Product code DSI·1989-10-02
K894692 — BEDSIDE MONITORS, BSM-8301A, BSM-8302ANihon Kohden America, Inc.·Product code DSI·1989-10-02
K894693 — AP-851PA NIBP MODULENihon Kohden America, Inc.·Product code DXN·1989-10-02
K894699 — TYPE 9140 (SYSTEM ATHENA)S & W Medico Teknik·Product code DRT·1989-10-02
K894700 — TYPE PDU/CDU 9040 (SYSTEM ATHENA)S & W Medico Teknik·Product code DRT·1989-10-02
K894834 — DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEMBrymill Corp.·Product code IYO·1989-10-02
K895158 — VISION WHOLE BLOOD HDL CHOLESTEROLAbbott Laboratories·Product code CHH·1989-10-02
K884711 — URETHRAL AND URETERAL BALLOON DILATATORSPrimrose Medical, Inc.·Product code EZN·1989-09-29
K884713 — COLONIC BALLOON DIALATORSPrimrose Medical, Inc.·Product code FFP·1989-09-29
K884714 — BILIARY DIALATORPrimrose Medical, Inc.·Product code FGE·1989-09-29
K884715 — ACHELASIA BALLOON DIALATORPrimrose Medical, Inc.·Product code KNQ·1989-09-29
K885229 — MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITSRomano Surgical Instrumentation, Inc.·Product code HSZ·1989-09-29
K891341 — PATIENT EXAMINATION GLOVES (LATEX)A.P. Rubber Co., Ltd.·Product code LYY·1989-09-29
K891481 — SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDESiemens Medical Electronics·Product code LKD·1989-09-29
K892145 — FIBER OPTIC LIGHT TRANSMISSION CABLEOpto Vision, Inc.·Product code FFS·1989-09-29
K893696 — PATIENT EXAM GLOVES(MFG: JIN DING ZAI JIE LATEX GLDouble Scores , Ltd.·Product code LYY·1989-09-29
K893726 — LATEX GLOVE, EXAMINATIONLixin Hygienical Products Factory Co., Ltd.·Product code LYY·1989-09-29
K894276 — CADWELL FREEDOM EEG DEVICECadwell Laboratories, Inc.·Product code GWQ·1989-09-29
K894337 — UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MMVitaid, Ltd.·Product code CBI·1989-09-29
K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELDAmersham Corp.·Product code IWA·1989-09-29
K894756 — DENVER PERITONEO-VENUS SHUNTCodman & Shurtleff, Inc.·Product code KPM·1989-09-29
K894786 — BIO-INDUSTRY STIM POCHE(R)The Hader Corp.·Product code BXN·1989-09-29
K894851 — TRU-TRAXHumagen, Inc.·Product code GIO·1989-09-29
K895343 — PRENATAL WEDGEKay Ent.·Product code JFB·1989-09-29
K895494 — EXCEL LATEX PATIENT EXAMINATION GLOVESAlpha Glove Sdn. Bhd.·Product code LYY·1989-09-29
K891588 — TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)Ideal Medical, Inc.·Product code LQR·1989-09-28
K891605 — COAT-A-COUNT(TM) FENTANYL (TKFN1)Diagnostic Products Corp.·Product code DJG·1989-09-28
K892586 — PATIENT EXAMINATION GLOVES (LATEX)Modlook Industries , Ltd.·Product code LYY·1989-09-28
K892655 — ACL DRILL GUIDE SYSTEMBaxter Healthcare Corp·Product code LXI·1989-09-28
K892904 — MITEK DRILL GUIDEMitek Surgical Products, Inc.·Product code HXY·1989-09-28
K893682 — KIT- CIBA CORNING L-TDM I, II, IIICiba Corning Diagnostics Corp.·Product code DIF·1989-09-28
K893718 — DELTATEST (R) LIPASE IIElectro-Nucleonics, Inc.·Product code CET·1989-09-28
K893843 — EZ-BEAD DIGOXIN EIA KITImmunotech Corp.·Product code KXT·1989-09-28
K894038 — PLUME-AWAY SMOKE EVACUATION SYSTEMLaser Technologies Group, Inc.·Product code FYD·1989-09-28
K894105 — TARGET THERAPEUTICS TRACKER LF CATHETERTarget Therapeutics·Product code DQY·1989-09-28
K894111 — VARI-SETSonex Medical·Product code LDR·1989-09-28
K894129 — BILIBLANKET PHOTOTHERAPY DEVICEOhmeda Medical·Product code LBI·1989-09-28
K894157 — OBTURATORArgon Medical Corp.·Product code DYB·1989-09-28
K894160 — HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPLArtech Corp.·Product code DZE·1989-09-28
K894193 — LATEX EXAMINATION GLOVESHasil Getah Gulungan Pertama·Product code LYY·1989-09-28
K894221 — ROSCO PYRRPro-Lab, Inc.·Product code JTO·1989-09-28
K894222 — TDXR ANALYZER WITH LITES TM LITHIUM CAROUSELAbbott Laboratories·Product code JJE·1989-09-28
K894310 — AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)American Research Products Co.·Product code CDT·1989-09-28
K894372 — NIPRO NEEDLE HOLDERPharma-Plast USA, Inc.·Product code FMI·1989-09-28
K894374 — BLOOD DRAWING NEEDLEPharma-Plast USA, Inc.·Product code FMI·1989-09-28
K894517 — FPR AMIKACIN KITColony Laboratories, Inc.·Product code KLQ·1989-09-28
K894518 — FPR AMIKACIN CALIBRATOR KITColony Laboratories, Inc.·Product code DLG·1989-09-28
K894523 — FPR GENTAMICIN KITColony Laboratories, Inc.·Product code LCQ·1989-09-28
K894524 — FPR GENTAMICIN CALIBRATOR KITColony Laboratories, Inc.·Product code DLG·1989-09-28
K894765 — SHARPLAN SMOKE EVACUATION UNIT, MODEL 100Laser Industries , Ltd.·Product code FYD·1989-09-28
K894804 — SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)Lifescan, Inc.·Product code JJX·1989-09-28
K894852 — SERACHEM PLUS CLINICAL CHEMISTRY CONTROLSInstrumentation Laboratory CO·Product code JJY·1989-09-28
K894962 — CO2 LASER BRONCHOSCOPE COUPLERCuda Products Co.·Product code GEX·1989-09-28
K894996 — EXUSORB(TM) GRANULESControlled Therapeutics Corp.·Product code FRO·1989-09-28
K895004 — MILENIA(TM) TOTAL IGE (MKIE1,5)Diagnostic Products Corp.·Product code DGC·1989-09-28
K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIMJohnson & Johnson International·Product code FRO·1989-09-28
K895353 — OPSITE I.V. 3000Smith & Nephew United, Inc.·Product code KGX·1989-09-28
K895398 — BIO-COORDINATOR SYSTEMBio-Harmonizer, Inc.·Product code IKK·1989-09-28
K895568 — PRIMIDONE (FPIA) CALIBRATOR KITTudor Laboratories, Inc.·Product code DLJ·1989-09-28
K895570 — VALPROIC ACID (FPIA) CALIBRATOR KITTudor Laboratories, Inc.·Product code DLJ·1989-09-28
K892635 — PATIENT EXAMINATION GLOVES (LATEX)P.T. Multi Latexindo·Product code LYY·1989-09-27
K893624 — PREEMICARE MODEL 2500 TRANSPORT WARMERPreemicare Corp.·Product code FPL·1989-09-27
K894150 — COUNTERBORE FOR SS SUBMERGED SCREW PLANTArtech Corp.·Product code DZJ·1989-09-27
K894151 — IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANTArtech Corp.·Product code DZJ·1989-09-27
K894298 — MODIFIED GEMINI ACETABULAR CUPDepuy, Inc.·Product code JDI·1989-09-27
K894414 — HEARING AID (IN-THE-CANAL)Hearing Aid Express·Product code ESD·1989-09-27
K894487 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+Y·Product code LDR·1989-09-27
K895042 — SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERYSharplan Lasers, Inc.·Product code GEX·1989-09-27
K895109 — SECONDARY IV SET WITH PROTECTED NEEDLEKendall Mcgaw Laboratories, Inc.·Product code FPA·1989-09-27
K895212 — TIK EXTRAKTORInstruments of Sweden, Inc.·Product code HTD·1989-09-27
K895258 — LATEX PATIENT EXAMINATION GLOVESPerfect Treasure Development , Ltd.·Product code LYY·1989-09-27
K895277 — ORTHO APO B ELISA TEST SYSTEMMedical Marketing Consultants, Inc.·Product code MSJ·1989-09-27
K895369 — VOSS GRAFT MARKERVoss Medical Products·Product code KPK·1989-09-27
K895598 — WAKO(TM) AUTOKIT CRPWako Chemicals USA, Inc.·Product code DCK·1989-09-27
K895670 — SURGICAL SUCTION APPARATUSBaker-Sundt Research, Inc.·Product code GEA·1989-09-27
K890597 — EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTSD-R Medical Systems, Inc.·Product code DSY·1989-09-26
K891513 — VINYL EXAMINATION GLOVESMann Chi Trading Co., Ltd.·Product code LYZ·1989-09-26
K892120 — ESCORT PULSE OXIMETRY OPTIONMedical Data Electronics·Product code DQA·1989-09-26
K892505 — PATIENT EXAMINATION GLOVESWango Intl., Inc.·Product code LYZ·1989-09-26
K892530 — CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPHArrow Intl., Inc.·Product code DYG·1989-09-26
K892760 — PATIENT EXAMINATION GLOVES (LATEX)Saha Import & Export Co.·Product code LYY·1989-09-26
K892851 — ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVERJohnson & Johnson Patient Care, Inc.·Product code FRO·1989-09-26
K892972 — 'JOBSTAR' PATIENT EXAMINATION GLOVESKai Sik Towa Rubber Products Sdn·Product code LYY·1989-09-26
K893017 — SWED MED STERILE VINYL EXAMINATION GLOVESNew England Glove Company·Product code LYZ·1989-09-26
K893105 — SAFETY TOUCH VINYL EXAMINATION GLOVESFedin Brothers Co., Inc.·Product code LYY·1989-09-26
K893336 — LATEX EXAMINATION GLOVESLai Sun Industrial Co.·Product code LYY·1989-09-26
K893435 — SILICONE FLOW-DIRECTED THERMODILUTION CATHETERCathlab Corp.·Product code DYG·1989-09-26
K893471 — MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORINGMedtronic Vascular·Product code DXH·1989-09-26
K893626 — FLEXMEDICS GUIDEWIREFlexmedics·Product code DQX·1989-09-26
K893685 — CERAMIC FEMORAL HEADDow Corning Wright·Product code LZO·1989-09-26
K893749 — CN GLOVESC.N. Technocrats·Product code LYY·1989-09-26
K894065 — OPUS MODEL 4001Ela Medical, Inc.·Product code DXY·1989-09-26
K894131 — DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000Thermedics, Inc.·Product code DQY·1989-09-26
K894138 — MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTDMedipart Jerry Alexander·Product code CAF·1989-09-26
K894182 — IMX TOTAL B-HCGAbbott Laboratories·Product code JHI·1989-09-26
K894255 — ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMPSt. Jude Medical, Inc.·Product code KFM·1989-09-26
K894277 — M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAMEHewlett-Packard Co.·Product code DXH·1989-09-26
K894281 — FIRST IMPRESSION WITH CHLORHEXIDINECoe Laboratories, Inc.·Product code ELW·1989-09-26

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