FDA 510(k) clearances — page 877

176,637 clearances on record, most recent first.

Clearances — page 877

87,601–87,700 of 176,637

K990547 — PILLING WECK SURGICAL Y STENT FORCEPSPilling Weck, Inc.·Product code EOQ·1999-04-27
K990610 — ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10Bio-Rad·Product code JJY·1999-04-27
K990870 — REDI-TEST THCRedwood Biotech, Inc.·Product code LDJ·1999-04-27
K990947 — MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERYLumenis, Inc.·Product code GEX·1999-04-27
K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.·Product code JJR·1999-04-27
K991067 — MODIFICATION OF: DAVIDSTRIP HCGSimex Medical, Inc.·Product code JHI·1999-04-27
K991277 — MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5Diagnostic Products Corp.·Product code DDR·1999-04-27
K983588 — SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUMIrvine Scientific Sales Co., Inc.·Product code MQL·1999-04-26
K983776 — EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMPEvenflo Co., Inc.·Product code HGX·1999-04-26
K990327 — RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSCoulter Corp.·Product code GKZ·1999-04-26
K990384 — EZFLOW CONTINUOUS NEBULIZER,MODEL 1005Piper Medical Products·Product code CAF·1999-04-26
K991151 — VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREWVilex, Inc.·Product code HWC·1999-04-26
K991197 — VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24Vilex, Inc.·Product code HWC·1999-04-26
K981311 — COWBOY XVKci New Technologies, Inc.·Product code JOW·1999-04-23
K983451 — CHALLENGE TEST PACKNorth American Science Assoc., Inc.·Product code JOJ·1999-04-23
K983579 — SYNTHETIC SERUM SUBSTITUTE (SSS)Irvine Scientific Sales Co., Inc.·Product code MQL·1999-04-23
K990425 — SIDEKICK INFUSION KITI-Flow Corp.·Product code FRN·1999-04-23
K990427 — ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREEAlliance Rubber Products Sdn. Bhd.·Product code LZA·1999-04-23
K990459 — EBI VUECATH ENDOSCOPIC SYSTENElectro-Biology, Inc.·Product code HRX·1999-04-23
K990485 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLORAlliance Rubber Products Sdn. Bhd.·Product code LZA·1999-04-23
K990486 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.Alliance Rubber Products Sdn. Bhd.·Product code LZA·1999-04-23
K990526 — KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMSsn Gloves (M) Sdn Bhd·Product code LYY·1999-04-23
K990527 — KLEENHANDS POWDERED LATEX EXAMINATION GLOVESSsn Gloves (M) Sdn Bhd·Product code LYY·1999-04-23
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical Industries·Product code EFQ·1999-04-23
K990982 — CAVIT LCEspe Dental AG·Product code EBF·1999-04-23
K991029 — RAPIDFLAP CRANIAL CLAMPWalter Lorenz Surgical, Inc.·Product code GXN·1999-04-23
K991044 — DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)Wrp Specialty Products Sdn. Bhd.·Product code LYY·1999-04-23
K991097 — PBN DRAINAGE CATHETER GUIDEWIRESMedical Device Technologies, Inc.·Product code KNY·1999-04-23
K991138 — LYSTA LC CURING LIGHT, MODEL LC 2500C/BALysta A/S·Product code EBZ·1999-04-23
K991294 — MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEMMedi-Ject Corp.·Product code KZE·1999-04-23
K990214 — FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEMSurgical Navigation Technologies, Inc.·Product code HAW·1999-04-22
K990312 — AVIA PAIN MEDICATION DELIVERY SYSTEMAmtec Medical·Product code MEA·1999-04-22
K990722 — ETEST FOR CEFUROXIMEAb Biodisk·Product code JWY·1999-04-22
K991027 — BI-DIRECTIONAL TUNNELERImpra, Inc.·Product code DSY·1999-04-22
K991195 — CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATVO-Two Systems Intl., Inc.·Product code BTL·1999-04-22
K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSGambro Healthcare·Product code KDI·1999-04-21
K983456 — ENSITE 3000 SYSTEMEndocardial Solutions, Inc.·Product code MTD·1999-04-21
K983732 — THORAX FD AND MULTIX FDSiemens Medical Solutions USA, Inc.·Product code MQB·1999-04-21
K984156 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTIONShimadzu Medical Systems·Product code JAK·1999-04-21
K984436 — PVS BASICSParagon Vision Sciences·Product code HQD·1999-04-21
K990175 — SHEATHES (NON-LATEX), STERILESheathing Technologies, Inc.·Product code ITX·1999-04-21
K990206 — SERIM BLOOD LEAK TEST STRIPSerim Research Corp.·Product code FJD·1999-04-21
K990367 — PDQ AND PDQ-TI ABUTMENTVident·Product code DZE·1999-04-21
K990371 — DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950Post Medical, Inc.·Product code FMI·1999-04-21
K990757 — CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPACantor & Silver , Ltd.·Product code LPL·1999-04-21
K990775 — URETERAL ACCESS SHEATH SETApplied Medical Resources·Product code FED·1999-04-21
K990858 — LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789Bio-Rad·Product code GGN·1999-04-21
K990915 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODYStellar Bio Systems, Inc.·Product code DHN·1999-04-21
K990916 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYStellar Bio Systems, Inc.·Product code KTL·1999-04-21
K990948 — S575 INTRAORAL DOCKING DENTAL CAMERASopro·Product code EIA·1999-04-21
K981995 — QUICKDRAW VENOUS CANNULAHeartport, Inc.·Product code DWF·1999-04-20
K982053 — EEG ELECTRODES MODEL 445 SERIESClass A Ent.·Product code GXY·1999-04-20
K983338 — FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095Nucletron Corp.·Product code JAQ·1999-04-20
K984589 — PHOTOTHERAPY LAMPMedela, Inc.·Product code LBI·1999-04-20
K990387 — ENDOMETRIAL SAMPLERU.A. Medical Products, Inc.·Product code HHK·1999-04-20
K990754 — CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50Diagnostic Chemicals , Ltd.·Product code KHS·1999-04-20
K990939 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMSelfcare, Inc.·Product code CGA·1999-04-20
K991130 — FLEXPLUGEagle Vision, Inc.·Product code LZU·1999-04-20
K980903 — RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COATRadionics, Inc.·Product code JXG·1999-04-19
K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111Dynamic Technology Corp.·Product code FJI·1999-04-19
K990189 — MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZERMidmark Corp.·Product code FLE·1999-04-19
K990199 — SMARTRECORDER, MODEL 2500Respironics, Inc.·Product code MNR·1999-04-19
K990434 — CARESIDE CKMBCareside, Inc.·Product code JHS·1999-04-19
K990439 — CARESIDE CKCareside, Inc.·Product code JHS·1999-04-19
K990972 — HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE THewlett-Packard GmbH·Product code DSI·1999-04-19
K983830 — COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETERMallinckroot, Inc.·Product code LIT·1999-04-16
K983948 — BEACON, MODEL 211060Philips Medical Systems (Cleveland), Inc.·Product code KPS·1999-04-16
K984446 — `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SHUrocor, Inc.·Product code KXK·1999-04-16
K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIESNihon Kohden America, Inc.·Product code LOS·1999-04-16
K990147 — BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771Richard Wolf Medical Instruments Corp.·Product code HIN·1999-04-16
K990248 — DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTIONDicomit Imaging Systems Corp.·Product code IYO·1999-04-16
K990281 — S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSNissel , Ltd.·Product code LPL·1999-04-16
K990406 — KINGLI ACUPUNCTURE NEEDLEUnited Pacific Co., Ltd.·Product code MQX·1999-04-16
K990458 — STRAUMANN EXTRAORAL IMPLANT SYSTEMStraumann USA·Product code KCZ·1999-04-16
K990715 — SHIMADZU CEILING TUBE SUPPORT CH-30GHShimadzu Corp.·Product code KPR·1999-04-16
K990824 — REVISED C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.·Product code JIT·1999-04-16
K990825 — REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGEDade Behring, Inc.·Product code DCN·1999-04-16
K990928 — LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405Bio-Rad·Product code DIE·1999-04-16
K991034 — CONVERTORS SURGICAL GOWNSAllegiance Healthcare Corp.·Product code FYA·1999-04-16
K974236 — MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SBMedical Components, Inc.·Product code MPB·1999-04-15
K982132 — BLEASE 6200 ANAESTHESIA VENTILATORBlease Medical Equipment , Ltd.·Product code CBK·1999-04-15
K983341 — STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SENucletron Corp.·Product code JAQ·1999-04-15
K984222 — QUANTA LITE LYME IGG ELISAInova Diagnostics, Inc.·Product code LSR·1999-04-15
K984234 — QUANTA LITE LYME IGM ELISAInova Diagnostics, Inc.·Product code LSR·1999-04-15
K984504 — NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIESNihon Kohden America, Inc.·Product code LOS·1999-04-15
K990010 — ALTHIN MEDICAL AB ALTRACART IIAlthin Medical AB·Product code KPO·1999-04-15
K990260 — OPARTToshiba America Mri, Inc.·Product code LNH·1999-04-15
K990399 — ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8Roche Diagnostics Corp.·Product code DKZ·1999-04-15
K990409 — ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)Roche Diagnostics Corp.·Product code DMY·1999-04-15
K990759 — VIEW COMElectromed Intl., Ltd.·Product code LLZ·1999-04-15
K990919 — STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAGVisualization Technology, Inc.·Product code LLZ·1999-04-15
K991018 — ACCUSIGN BAR, BIOSIGN BAR, STATUS BARPrinceton BioMeditech Corp.·Product code DIS·1999-04-15
K991076 — ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCPPrinceton BioMeditech Corp.·Product code DIS·1999-04-15
K991078 — ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8Princeton BioMeditech Corp.·Product code DKE·1999-04-15
K991079 — ACCUSIGN BZO, BIOSIGN BZO, STATUS BZOPrinceton BioMeditech Corp.·Product code JXM·1999-04-15
K991080 — ACCUSIGN MTD, BIOSIGN MTDPrinceton BioMeditech Corp.·Product code DJR·1999-04-15
K991082 — ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZOPrinceton BioMeditech Corp.·Product code DIS·1999-04-15
K991084 — ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTDPrinceton BioMeditech Corp.·Product code DIS·1999-04-15
K982134 — DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851Dynamic Technology Corp.·Product code KDI·1999-04-14
K982144 — MEGA 4Mega Motion, Inc.·Product code INI·1999-04-14

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