FDA 510(k) clearances — page 860

176,637 clearances on record, most recent first.

Clearances — page 860

85,901–86,000 of 176,637

K993178 — UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50Diagnostic Chemicals , Ltd.·Product code CDQ·1999-10-18
K983616 — DAIWA MODEL 180Daiwa Products, Inc.·Product code DXN·1999-10-15
K990401 — FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLERFukuda Denshi USA, Inc.·Product code IYO·1999-10-15
K990750 — DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILEWrp Specialty Products Sdn. Bhd.·Product code LZA·1999-10-15
K991025 — LUMA-CATH FIXED CURVE EP CATHETERSIrvine Biomedical, Inc.·Product code DRF·1999-10-15
K991203 — IRRIGATION OR INFUSION PUMP K PUMPKmi Kolster Methods, Inc.·Product code FRN·1999-10-15
K992394 — BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENTEndotec, Inc.·Product code HSD·1999-10-15
K992410 — ACTITRACIndividual Monitoring Systems, Inc.·Product code GWQ·1999-10-15
K992416 — PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATEUsbiomaterials Corp.·Product code LYC·1999-10-15
K992435 — BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZERAzo Enterprises·Product code EFW·1999-10-15
K992469 — KSEA SCBCOMKarl Storz Endoscopy·Product code FET·1999-10-15
K992478 — PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810AHewlett-Packard, Healthcare Solutions Group·Product code DXN·1999-10-15
K992511 — ABX PENTRA 60 HEMATOLOGY ANALYZERAbx Diagnostics·Product code GKZ·1999-10-15
K992591 — CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITSCodman & Shurtleff, Inc.·Product code GWM·1999-10-15
K992816 — MODIFICATION TO INTRASTENTIntratherapeutics, Inc.·Product code FGE·1999-10-15
K992870 — POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIAlliance Rubber Products Sdn. Bhd.·Product code LYY·1999-10-15
K992878 — ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TESTImmco Diagnostics, Inc.·Product code MVM·1999-10-15
K993148 — STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGAStryker Instruments·Product code FYA·1999-10-15
K993233 — OBC-085 BREAST ARRAY COILMri Devices Corp.·Product code MOS·1999-10-15
K993235 — QWH-085 WRIST ARRAY COILMri Devices Corp.·Product code MOS·1999-10-15
K993279 — QSC-085 SHOULDER ARRAY COILMri Devices Corp.·Product code MOS·1999-10-15
K983808 — ZIPPYPillar Technology, Inc.·Product code ITI·1999-10-14
K990372 — MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERYDr. Fritz GmbH·Product code HET·1999-10-14
K990986 — CONTOUR SPINAL SYSTEMOrtho Development Corp.·Product code KWP·1999-10-14
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.·Product code MGP·1999-10-14
K992145 — ECOMED SCALP VEIN SETGreiner Meditech, Inc.·Product code FPA·1999-10-14
K992382 — SURGITRON RADIOLASEEllman Intl., Inc.·Product code GEI·1999-10-14
K992458 — RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454Innovasive Devices, Inc.·Product code MBI·1999-10-14
K992484 — RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNGJordco, Inc.·Product code KJJ·1999-10-14
K992555 — SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Vision Plastic Products Co., LT·Product code LYZ·1999-10-14
K992568 — PASCO MIC AND MIC/ID PANELS, CEFOTAXIMEPasco Laboratories, Inc.·Product code JTN·1999-10-14
K992593 — PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOLPasco Laboratories, Inc.·Product code JTN·1999-10-14
K992612 — ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232Ethicon Endo-Surgery, Inc.·Product code GCJ·1999-10-14
K992742 — NEUROFAX, MODEL EEG-1100ANihon Kohden America, Inc.·Product code OLV·1999-10-14
K992764 — ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103Erbe USA, Inc.·Product code GEI·1999-10-14
K992769 — ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-Erbe USA, Inc.·Product code GEI·1999-10-14
K992847 — HICHEM BUN REAGENTElan Holdings, Inc.·Product code LFP·1999-10-14
K992985 — GLUMA COMFORT BONDHeraeus Kulzer, Inc.·Product code KLE·1999-10-14
K993002 — CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15Ceram Optec, Inc.·Product code GEX·1999-10-14
K993089 — DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTERDeroyal Cardiovascular, Inc.·Product code FTA·1999-10-14
K993159 — MAXIM KNEE SYSTEMBiomet, Inc.·Product code JWH·1999-10-14
K991205 — ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)Allegiance Healthcare Corp.·Product code KGO·1999-10-13
K991563 — CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CHenke Sass Wolf of America, Inc.·Product code HIH·1999-10-13
K992369 — SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22Interpore Cross Intl.·Product code MNI·1999-10-13
K992372 — THE LEADAWAYTherapy Equipment, Inc.·Product code IKD·1999-10-13
K992380 — ENDO-EZE MOTOR AND HANDPIECEUltradent Products, Inc.·Product code EFB·1999-10-13
K992426 — RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.·Product code LMD·1999-10-13
K992431 — NEO-2 METERAutomata Instrumentation, Inc.·Product code FIZ·1999-10-13
K992527 — URETERO-RENOSCOPEFiber Imaging Technologies, Inc.·Product code FGB·1999-10-13
K992547 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22Canon USA, Inc.·Product code MQB·1999-10-13
K992562 — PASCO MIC AND MIC/ID PANELS, CEFTRIAXONEPasco Laboratories, Inc.·Product code JTN·1999-10-13
K992666 — VIDEO PLUS SYSTEM, SERIES 95000Camtronics, Ltd.·Product code LLZ·1999-10-13
K992768 — NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVEAnsell Perry·Product code LZA·1999-10-13
K992865 — SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVEMaxxim Medical·Product code LYZ·1999-10-13
K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800Sulzer Carbomedics, Inc.·Product code KRH·1999-10-12
K992354 — SNT IMAGE ANALYSIS SYSTEMSurgical Navigation Technologies, Inc.·Product code LLZ·1999-10-12
K992360 — TG MEDICAL POWDERED NITRILE EXAMINATION GLOVESTg Medical Sdn. Bhd.·Product code LZA·1999-10-12
K992546 — PASCO MIC AND MIC/ID PANELS, MEROPENEMPasco Laboratories, Inc.·Product code JTN·1999-10-12
K992673 — VISTA BRITE TIP CATHETERSCordis Corp.·Product code DQY·1999-10-12
K983864 — ETCO2 VITAL SIGNS MODULEMennen Medical, Inc.·Product code CCK·1999-10-08
K990153 — VIRGO MRI SYSTEMMillennium Technology Services·Product code LNH·1999-10-08
K991256 — VIEWPOINT ENT/ORTHOPEDIC OPTIONPhilips Medical Systems (Cleveland), Inc.·Product code HAW·1999-10-08
K991487 — CIDEX OPA SOLUTIONAdvanced Sterilization Products·Product code MED·1999-10-08
K991658 — PERMOBIL POWERED WHEELCHAIR 1280Permobil AB·Product code ITI·1999-10-08
K991709 — BROWNE CIDEX OPA INDICATORAlbert Browne , Ltd.·Product code JOJ·1999-10-08
K992195 — QUANTEC-E IRRIGATION SYSTEM 2Sybron Dental Specialties, Inc.·Product code EIA·1999-10-08
K992238 — MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)Masimo Corp.·Product code DQA·1999-10-08
K992319 — RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEMGuidant Corp.·Product code FGE·1999-10-08
K992326 — 3M CLINPRO SEALANT3M Company·Product code EBC·1999-10-08
K992333 — EBI OMEGA 21 SYSTEMElectro-Biology, Inc.·Product code MNI·1999-10-08
K992334 — ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATINGImplant Innovations, Inc.·Product code DZE·1999-10-08
K992340 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEMasimo Corp.·Product code DQA·1999-10-08
K992347 — CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSCordis Corp.·Product code DQO·1999-10-08
K992351 — SEALOUETTE FIBRIN SEALANT APPLICATORBiosurgical Corp.·Product code FMF·1999-10-08
K992366 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACKOrtho-Clinical Diagnostics, Inc.·Product code MMI·1999-10-08
K992377 — RC TACKInnovasive Devices, Inc.·Product code MBI·1999-10-08
K992409 — THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZImplex Corp.·Product code JDI·1999-10-08
K992507 — PASCO MIC AND MIC/ID PANELS, TROVAFLOXACINPasco Laboratories, Inc.·Product code JTN·1999-10-08
K992536 — TECHNOSANAT KRYO TSK 2005Technosanat Innovative Medizintechnik GmbH·Product code GEX·1999-10-08
K992650 — AIRIS, AIRIS IIHitachi Medical Systems America, Inc.·Product code MOS·1999-10-08
K993025 — MODIFICATION TO BONE MULCH SCREW SYSTEMBiomet, Inc.·Product code HWC·1999-10-08
K993065 — ACON COMBO PREGNANCYACON Laboratories, Inc.·Product code JHI·1999-10-08
K993077 — HOWMEDICA OSTEONICS RESTORATION HA HIP STEMHowmedica Osteonics Corp.·Product code MEH·1999-10-08
K993088 — PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCIPuritan Bennett Corp.·Product code CAW·1999-10-08
K993098 — HDL-C/LDL-C CALIBRATOR, MODEL 1913-003Data Medical Associates, Inc.·Product code JIX·1999-10-08
K984590 — 0.9% SODIUM CHLORIDE FLUSH SYRINGEBaxter Healthcare Corp·Product code FOZ·1999-10-07
K990638 — ANEROID SPHYGMOMANOMETERGenmed, Inc.·Product code DXN·1999-10-07
K990990 — CET PROSTATE APPLICATOR SET, PART NUMBER 089.066Nucletron Corp.·Product code JAQ·1999-10-07
K991452 — COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATORCobe Cardiovascular, Inc.·Product code DTZ·1999-10-07
K991687 — MODIFICATION TO LINER II: SOFT RELINE LIQUIDBosworth Co.·Product code EBI·1999-10-07
K991857 — AIRFLOW HANDYElectro Medical Systems, Inc.·Product code EFB·1999-10-07
K992028 — REFRESH CONTACTS LUBRICATING AND REWETTING DROPSAllergan, Inc.·Product code LPN·1999-10-07
K992309 — INTRODUCER SHEATH, VESSEL DILATORBoston Scientific Corp·Product code DYB·1999-10-07
K992335 — BEACON-P, MODEL 211059Philips Medical Systems (Cleveland), Inc.·Product code KPS·1999-10-07
K992450 — EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERSEmory University·Product code KPS·1999-10-07
K992575 — CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000Infimed, Inc.·Product code LLZ·1999-10-07
K992696 — ECG MINIMONITOR, MODEL CG-5000Card Guard Scientific Survival , Ltd.·Product code DXH·1999-10-07
K992869 — XOMED BALL-TIP MONOPOLAR STIMULATOR PROBEXomed, Inc.·Product code ETN·1999-10-07
K992966 — REFERENCEEspe Dental AG·Product code EBF·1999-10-07
K992983 — BAHO AUTOCLAVABLE CYSTOSCOPEInnovative Endoscopy Components, LLC·Product code FAJ·1999-10-07

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