FDA 510(k) clearances — page 898

176,637 clearances on record, most recent first.

Clearances — page 898

89,701–89,800 of 176,637

K982459 — TEMPFIL F - 2Sybron Dental Specialties, Inc.·Product code EBG·1998-09-30
K982463 — EXTRACRANIAL RADIOTHERAPY SYSTEMHowmedica, Inc.·Product code IYE·1998-09-30
K982482 — HANDMASTER NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst·Product code IPF·1998-09-30
K982509 — ORTHO IMPLANT AND ACCESSORIESStraumann USA·Product code OAT·1998-09-30
K982620 — MEDIVISION CYSTOSCOPEMedivision Scope Service Center, Inc.·Product code FAJ·1998-09-30
K982623 — AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEMAesculap, Inc.·Product code GCJ·1998-09-30
K982648 — JOAN IICelanese Acetate Co.·Product code EFQ·1998-09-30
K982704 — DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREEShanghai Antares Industries, Inc.·Product code LYZ·1998-09-30
K982752 — SEARE BIOMEDICAL CHIN IMPLANTSSeare Biomedical Corp.·Product code FWP·1998-09-30
K982753 — SEARE BIOMEDICAL NASAL IMPLANTSSeare Biomedical Corp.·Product code FZE·1998-09-30
K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.·Product code MIC·1998-09-30
K982763 — SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.·Product code LZK·1998-09-30
K982779 — MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1Medental Intl.·Product code EMA·1998-09-30
K982781 — DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINERThermal Waste Technology, Inc.·Product code MMK·1998-09-30
K982806 — CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVEPerusahaan Getah Asas Sdn. Bhd.·Product code LYY·1998-09-30
K982807 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVEPerusahaan Getah Asas Sdn. Bhd.·Product code LYY·1998-09-30
K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72Baxter Healthcare Corp·Product code CAK·1998-09-30
K982868 — ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAEAb Biodisk·Product code JWY·1998-09-30
K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.·Product code DTS·1998-09-30
K983041 — SEARE BIOMEDICAL SILICONE SHEETINGSeare Biomedical Corp.·Product code MIB·1998-09-30
K983043 — SEARE BIOMEDICAL SILICONE BLOCKSeare Biomedical Corp.·Product code MIC·1998-09-30
K983161 — KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOCSabre-K , Ltd.·Product code ELR·1998-09-30
K974813 — COMBISON 530D WITH POWER DOPPLER MODEMedison America, Inc.·Product code IYN·1998-09-29
K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAYDigene Corp.·Product code LJO·1998-09-29
K981055 — XKNIFE-4Radionics, Inc.·Product code IYE·1998-09-29
K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEMDiamedix Corp.·Product code LGC·1998-09-29
K981553 — AUTOMATED MEDICAL REPORT WRITERWoodson and Associates, LLC·Product code KPS·1998-09-29
K981834 — PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEMPerception, Inc.·Product code IYN·1998-09-29
K982446 — DYNAMIC SHIELDING RADIATION TABLEAmerican Biophysics, Inc.·Product code JAI·1998-09-29
K982983 — LSVP INTERNATIONAL BIOPSY FORCEPSLsvp Intl., Inc.·Product code EOQ·1998-09-29
K982993 — PHILIPS OMNIDIAGNOSTPhilips Medical Systems, Inc.·Product code OWB·1998-09-29
K983130 — LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSKamiya Biomedical Co.·Product code JJY·1998-09-29
K983241 — ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSKamiya Biomedical Co.·Product code JJY·1998-09-29
K980997 — PGK DEVICE (MODIFIED)Pgk, Inc.·Product code IWJ·1998-09-28
K981226 — IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3Dako Diagnostics , Ltd.·Product code GQP·1998-09-28
K981394 — BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720Braemar Corp.·Product code DXH·1998-09-28
K981817 — COAMATIC PLASMIN INHIBITORInstrumentation Laboratory CO·Product code GGP·1998-09-28
K981867 — IS-VZU IGG TEST SYSTEMDiamedix Corp.·Product code LFY·1998-09-28
K982382 — COBAS INTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.·Product code CFN·1998-09-28
K983131 — ASTAbbott Laboratories·Product code CIT·1998-09-28
K983147 — ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PPrinceton BioMeditech Corp.·Product code DKE·1998-09-28
K971924 — BLUNT SYRINGE CANNULAB.Braun Medical, Inc.·Product code FMI·1998-09-25
K973637 — PRESS-MATE ADVANTAGEColin Medical Instruments Corp.·Product code DXN·1998-09-25
K980817 — PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30LInterpore Intl.·Product code MQV·1998-09-25
K981299 — SILVERLON CONTACT WOUND DRESSINGArgentum International, LLC·Product code FRO·1998-09-25
K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIESDexide, Inc.·Product code GCJ·1998-09-25
K982266 — HYDROCISION ARTHROJET SYSTEMHydrocision, Inc.·Product code HRX·1998-09-25
K982279 — VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200Bci Intl., Inc.·Product code MHX·1998-09-25
K982300 — TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701AToshiba America Medical Systems, In.C·Product code KPS·1998-09-25
K982304 — DEVILBISS SUCTION UNITSunrise Medical Hhg, Inc.·Product code JCX·1998-09-25
K982330 — DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANTDepuy, Inc.·Product code FTM·1998-09-25
K982481 — A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITORA&D Engineering, Inc.·Product code DXN·1998-09-25
K982719 — THE BONE TIESurgicraft , Ltd.·Product code HTY·1998-09-25
K982842 — HUMAPEN AND HUMAPEN ERGOEli Lilly and Co.·Product code FMF·1998-09-25
K983123 — POC ENT ENDOSCOPE - SINUSCOPEPrecision Optics Corp.·Product code EOB·1998-09-25
K983152 — OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWSOsteonics Corp.·Product code MNH·1998-09-25
K974572 — GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820Chugai Pharmaceuticals Co., Ltd.·Product code MDK·1998-09-24
K981564 — AIR TECHNIQUES' AIRDENT IIAir Techniques, Inc.·Product code KOJ·1998-09-24
K981985 — ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209Beckman Coulter, Inc.·Product code DHX·1998-09-24
K982172 — CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COLCoulter Corp.·Product code GKZ·1998-09-24
K982230 — LASETTE LASER SKIN PERFORATORCell Robotics, Inc.·Product code GEX·1998-09-24
K982954 — FREE T4 MICROWELL EIA, MODEL #7019Biomerica, Inc.·Product code CEC·1998-09-24
K983176 — ELECSYS MYOGLOBIN STAT ASSAYBoehringer Mannheim Corp.·Product code DDR·1998-09-24
K974899 — GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO HGambro Healthcare·Product code FIP·1998-09-23
K981069 — ULTRA-COVER PU-TRANSDUCER COVERInternational Medical Products B.V.·Product code ITX·1998-09-23
K982244 — MAYFIELD ACCISS OPTICAL SYSTEMOhio Medical Instrument Co., Inc.·Product code HAW·1998-09-23
K982400 — STERI-OSS' IMPROV TEMPORARY DENTAL CEMENTSteri-Oss, Inc.·Product code EMA·1998-09-23
K982427 — TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-CTrex Medical Corp.·Product code OWB·1998-09-23
K982817 — EWC: ECG CABLE AND LEADWIRE SYSTEMSEwc·Product code DSA·1998-09-23
K982960 — MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENTMedical Device Technologies, Inc.·Product code KNW·1998-09-23
K982962 — XENON LIGHT SOURCE, MODELS LS6180, LS6035Contec Medical Vision, Ltd.·Product code GCT·1998-09-23
K983134 — NBILAbbott Laboratories·Product code MQM·1998-09-23
K972309 — JM-102 JAUNDICE METERAir-Shields, Inc.·Product code MQM·1998-09-22
K973721 — BIONECT HYDROGEL GAUZE PADSFidia Pharmaceutical Corp.·Product code MGQ·1998-09-22
K973722 — BIONECT HYDROGEL FOAMFidia Pharmaceutical Corp.·Product code MGQ·1998-09-22
K973724 — BIONECT HYDROGEL SPRAYFidia Pharmaceutical Corp.·Product code MGQ·1998-09-22
K973725 — BIONECT CLEAR HYDROGELFidia Pharmaceutical Corp.·Product code MGQ·1998-09-22
K974226 — IMMUNODOT MONO-G TESTGenbio·Product code LSE·1998-09-22
K974244 — IMMUNODOT MONO-M TESTGenbio·Product code LSE·1998-09-22
K974685 — OSTEONICS POLYETHYLENE ACETABULAR COMPONENTSOsteonics Corp.·Product code JDI·1998-09-22
K980398 — KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN IIOptomedic Medical Technologies , Ltd.·Product code GEX·1998-09-22
K980798 — BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTPrinceton BioMeditech Corp.·Product code LYR·1998-09-22
K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTAFibra Sonics, Inc.·Product code LFL·1998-09-22
K981260 — KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MClinical Innovations, Inc.·Product code HDB·1998-09-22
K981734 — VTEC-RPLA SEIKENDenka Seiken'S·Product code GNA·1998-09-22
K982063 — ALM PRISMALIX (PRX) SURGICAL LIGHTAlm Surgical Equipment, Inc.·Product code FSY·1998-09-22
K982073 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEMAnchor Products Co.·Product code GCJ·1998-09-22
K982221 — PREMIER APAmerican Imex·Product code GZJ·1998-09-22
K982259 — CHROMA ZONE COLOR STAINKuraray America, Inc.·Product code EBF·1998-09-22
K982271 — WAKO DIRECT LDL-CWako Chemicals USA, Inc.·Product code MRR·1998-09-22
K982305 — SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENTSulzer Calcitek, Inc.·Product code DZE·1998-09-22
K982306 — POLYTUBEFerris Mfg. Corp.·Product code MGQ·1998-09-22
K982319 — CAREGRAPHSiemens Medical Solutions USA, Inc.·Product code JAA·1998-09-22
K982403 — BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXBrennen Medical, Inc.·Product code PAG·1998-09-22
K982475 — SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOLTissue Technologies, Inc.·Product code FTL·1998-09-22
K982542 — STRYKER URETERAL ILLUMINATOR SYSTEM IIIStryker Endoscopy·Product code FCS·1998-09-22
K982546 — PHASER-2000Diomedics, Inc.·Product code ILY·1998-09-22
K982553 — OSTEO COMPRESSION HIP SCREW SYSTEMOsteonics Corp.·Product code HRS·1998-09-22
K982565 — EASY TRANS TIPCarl Schuh·Product code KXO·1998-09-22
K982571 — KSEA FLIPPTACKKARL STORZ Endoscopy-America, Inc.·Product code MBI·1998-09-22

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