FDA 510(k) clearances — page 880

176,637 clearances on record, most recent first.

Clearances — page 880

87,901–88,000 of 176,637

K984584 — AIR TECHNIQUES' DENTO-VACAir Techniques, Inc.·Product code EIA·1999-03-22
K990090 — DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTUREAesculap, Inc.·Product code GAR·1999-03-22
K990118 — ISOBAR SPINAL SYSTEMScien'Tx USA, Inc.·Product code MNH·1999-03-22
K990249 — OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031Phamatech·Product code CEP·1999-03-22
K990297 — ETEST MINOCYCLINEAb Biodisk·Product code JWY·1999-03-22
K990334 — KSEA ENDOSCOPE HOLDERKARL STORZ Endoscopy-America, Inc.·Product code OCV·1999-03-22
K990389 — MOSS GASTROSTOMY TUBEMoss Tubes, Inc.·Product code KNT·1999-03-22
K990393 — ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05Bio-Rad·Product code JJX·1999-03-22
K990460 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)Roche Diagnostics Corp.·Product code JIX·1999-03-22
K990553 — IGM FLEX REAGENT CARTRIDGEDade Behring, Inc.·Product code CFQ·1999-03-22
K990554 — DIMENSION SPECIAL PROTEIN CALIBRATORDade Behring, Inc.·Product code JIT·1999-03-22
K990555 — TISPORT X AND TISPORT XCTisport·Product code IOR·1999-03-22
K990557 — THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIRPdg Product Design Group, Inc.·Product code IOR·1999-03-22
K990707 — MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERSMedtronics Interventional Vascular·Product code DQY·1999-03-22
K990725 — NUVOLASE 532 LASER SYSTEMAmerican Laser Corp.·Product code GEX·1999-03-22
K990780 — NUVOLASE 532 CUTANEOUS LASER SYSTEMAmerican Laser Medical·Product code GEX·1999-03-22
K974393 — VASO PRESS SYSTEMBritt Corp., Inc.·Product code JOW·1999-03-19
K983360 — MACROPORE PROTECTIVE SHEETPacific Materials and Interfaces·Product code JEY·1999-03-19
K983572 — SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500Healthdyne Technologies, Inc.·Product code MNR·1999-03-19
K984345 — AROMAPATCHEnvis, Inc.·Product code LRD·1999-03-19
K984449 — NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIMP.T. Irama Dinamika Latex·Product code LYY·1999-03-19
K984547 — DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDSResound Corp.·Product code EWO·1999-03-19
K990042 — SILON DUAL-DRESSBio Med Sciences, Inc.·Product code FRO·1999-03-19
K990101 — PAIN CONTROL INFUSION PUMPSgarlato Laboratories, Inc.·Product code FRN·1999-03-19
K990134 — MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)Toshiba America Medical Systems, In.C·Product code JAK·1999-03-19
K990184 — AUTOMARQERHamilton Thorne Research·Product code POV·1999-03-19
K990534 — EXCITEIvoclar North America, Inc.·Product code KLE·1999-03-19
K990563 — SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTIONSiemens Medical Solutions USA, Inc.·Product code MHX·1999-03-19
K990629 — SYMBIOCERAMNey Dental, Inc.·Product code EIH·1999-03-19
K990646 — PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATENsk Nakanishi, Inc.·Product code EKX·1999-03-19
K990720 — SAS HCG SERUM CONTROLSSa Scientific, Inc.·Product code JJX·1999-03-19
K990755 — SAS HCG URINE CONTROLSSa Scientific, Inc.·Product code JJX·1999-03-19
K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.·Product code LKT·1999-03-18
K983624 — GILTECH PLUS CONNECTING TUBE SETGiltech Plus, Inc.·Product code KDH·1999-03-18
K983656 — HSV-1 AND/OR -2 IGM ELISA TEST SYSTEMZeus Scientific, Inc.·Product code LGC·1999-03-18
K984006 — GLUCOMETER ELITE XL BLOOD GLUCOSE METERBayer Corp.·Product code CGA·1999-03-18
K984102 — ACL/APS FACS KITLouisville Apl Diagnostics, Inc.·Product code MID·1999-03-18
K990036 — CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000Careside, Inc.·Product code JGS·1999-03-18
K990296 — CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)Precision Biologic·Product code GJT·1999-03-18
K990317 — ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01Bio-Rad·Product code JJY·1999-03-18
K990394 — ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02Bio-Rad·Product code JJY·1999-03-18
K981153 — OSIRISHuestis Medical·Product code IYE·1999-03-17
K982160 — HINGED KNEEEncore Orthopedics, Inc.·Product code KRO·1999-03-17
K982816 — VNUS CLOSURE SYSTEMVnus Medical Technologies, Inc.·Product code GEI·1999-03-17
K983500 — PRO2 CHECK OXYGEN INDICATORMedical Technology Specialists, Inc.·Product code CCL·1999-03-17
K983945 — CORTEX DERMASCAN C ULTRASONIC SYSTEMCortex Technology Aps·Product code IYO·1999-03-17
K984081 — EMOXEmox 911 CC·Product code CAW·1999-03-17
K984434 — MEDIVISION LAPAROSCOPEMedivision Scope Service Center, Inc.·Product code GCJ·1999-03-17
K984521 — RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351Richard Wolf Medical Instruments Corp.·Product code EQL·1999-03-17
K984587 — ALLROUND-E (CODE NAME RD 1710)J.F. Jelenko & Co., Inc.·Product code EJS·1999-03-17
K984628 — MODIFICATION OF MOSS P.E.G. TRAYMoss Tubes, Inc.·Product code KNT·1999-03-17
K990066 — CCD CAMERA, MODEL 9000Camtronics, Ltd.·Product code LMA·1999-03-17
K990146 — SURGITRONEllman Intl., Inc.·Product code GEI·1999-03-17
K990481 — ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEMBiodynamic Technologies, Inc.·Product code HRS·1999-03-17
K990513 — ULTIMAX CORTICAL BONE SCREWSBiodynamic Technologies, Inc.·Product code HWC·1999-03-17
K980688 — INTEGRITI PATIENT MONITORAlliance Instruments·Product code MWI·1999-03-16
K984216 — IMMUNO-TROL CONTROL CELLSCoulter Corp.·Product code JPK·1999-03-16
K984466 — DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5Dilon Technologies, Inc.·Product code IYX·1999-03-16
K984582 — ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXXBio-Detek, Inc.·Product code MKJ·1999-03-16
K990009 — CARESIDE ASTCareside, Inc.·Product code CIT·1999-03-16
K990293 — ALADDIN II MONITORING OXYGEN/AIR MONITORHamilton Medical, Inc.·Product code BZR·1999-03-16
K980840 — LOKKI DTHillard W. Welch·Product code GEX·1999-03-15
K981955 — MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMSLs Rubber Sdn Bhd·Product code LTZ·1999-03-15
K983119 — ENTERO-TEST HP, MODEL #102-01Hdc Corp.·Product code LIO·1999-03-15
K983202 — HARWILL MEDICAL CERVITULA CERVICAL SPATULAHarwill Medical (Pty) , Ltd.·Product code HHT·1999-03-15
K983228 — BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000Murray Electronics·Product code NYN·1999-03-15
K983295 — BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520Braun AG·Product code FLL·1999-03-15
K983385 — HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERSHutchison Intl., Inc.·Product code LCJ·1999-03-15
K983742 — ITI DENTAL IMPLANT SYSTEMInstitut Straumann AG·Product code DZE·1999-03-15
K983835 — IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLAImplex Corp.·Product code JWH·1999-03-15
K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400Micro-Medical Devices, Inc.·Product code HXR·1999-03-15
K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MMSurgical Laser Technologies, Inc.·Product code GEI·1999-03-15
K984190 — BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.·Product code HST·1999-03-15
K984427 — EXCELSIOR PORCELAIN SYSTEMNey Dental, Inc.·Product code EIH·1999-03-15
K984492 — TIGRAN HIP PROSTHESISPonmed , Ltd.·Product code LPH·1999-03-15
K984534 — PRECLUDE ACUSEAL DURA SUBSTITUTEW. L. Gore & Associates, Inc.·Product code GXQ·1999-03-15
K984583 — THE BIOPLATE SHUNT CONNECTORBiomedics·Product code JXG·1999-03-15
K990019 — DRG MEDIUM SCREW SYSTEMDolphin Medical Technologies, Inc.·Product code HWC·1999-03-15
K990089 — SILKAM NONABSORBABLE SILK SURGICAL SUTUREAesculap, Inc.·Product code GAP·1999-03-15
K990152 — OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHERHowmedica Osteonics Corp.·Product code HSB·1999-03-15
K990309 — PLUS FRACTURE HEAD PROSTHESISPlus Orthopedics·Product code KWL·1999-03-15
K990391 — ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01Bio-Rad·Product code JJY·1999-03-15
K990423 — PHILIPS NICOL COLLIMATOR FAMILYPhilips Medical Systems, Inc.·Product code IZW·1999-03-15
K990463 — MEDLINE EXCEL WHEELCHAIRSMedline·Product code IOR·1999-03-15
K990598 — OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEADHowmedica Osteonics Corp.·Product code KWS·1999-03-15
K990606 — TETRAFILCON ACooperVision, Inc.·Product code LPL·1999-03-15
K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NOFlexmedics·Product code OCY·1999-03-15
K990805 — MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETERCordis Corp.·Product code QEZ·1999-03-15
K980964 — MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMSLs Rubber Sdn Bhd·Product code HIS·1999-03-12
K982466 — IMMULITE THYROGLOBULIN MODEL LKTYDiagnostic Products Corp.·Product code MSW·1999-03-12
K982468 — IMMULITE 2000 THYROGLOBULIN MODEL L2KTYDiagnostic Products Corp.·Product code MSW·1999-03-12
K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)Wembley Rubber Products (M) Sdn Bhd·Product code KGO·1999-03-12
K982739 — GYNEX ELECTRODESGynex Corp.·Product code HGI·1999-03-12
K983355 — SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITORSabratek Corp.·Product code FLL·1999-03-12
K983843 — BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238BArthrex, Inc.·Product code MAI·1999-03-12
K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)Mastek, Inc.·Product code IXA·1999-03-12
K984289 — VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACKOrtho-Clinical Diagnostics, Inc.·Product code LTJ·1999-03-12
K984518 — SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.·Product code ESD·1999-03-12
K984580 — BIOSACA SYSTEMBiosys AB (Publ)·Product code OLV·1999-03-12
K984634 — 3D-ANGIOSiemens Medical Corp.·Product code JAK·1999-03-12

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