Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW (K981858)Atlantis Components, Inc.1999-03-22
PAIN CONTROL INFUSION PUMP (K990101)Sgarlato Laboratories, Inc.1999-03-19
SAS HCG SERUM CONTROLS (K990720)Sa Scientific, Inc.1999-03-19
AUTOMARQER (K990184)Hamilton Thorne Research1999-03-19
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS (K984547)Resound Corp.1999-03-19
SYMBIOCERAM (K990629)Ney Dental, Inc.1999-03-19
AROMAPATCH (K984345)Envis, Inc.1999-03-19
MACROPORE PROTECTIVE SHEET (K983360)Pacific Materials and Interfaces1999-03-19
MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) (K990134)Toshiba America Medical Systems, In.C1999-03-19
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION (K990563)Siemens Medical Solutions USA, Inc.1999-03-19
SILON DUAL-DRESS (K990042)Bio Med Sciences, Inc.1999-03-19
EXCITE (K990534)Ivoclar North America, Inc.1999-03-19
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM (K984449)P.T. Irama Dinamika Latex1999-03-19
SAS HCG URINE CONTROLS (K990755)Sa Scientific, Inc.1999-03-19
VASO PRESS SYSTEM (K974393)Britt Corp., Inc.1999-03-19
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE (K990646)Nsk Nakanishi, Inc.1999-03-19
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 (K983572)Healthdyne Technologies, Inc.1999-03-19
GILTECH PLUS CONNECTING TUBE SET (K983624)Giltech Plus, Inc.1999-03-18
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336)Diagnostic Products Corp.1999-03-18
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 (K990317)Bio-Rad1999-03-18
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 (K990036)Careside, Inc.1999-03-18
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (K983656)Zeus Scientific, Inc.1999-03-18
GLUCOMETER ELITE XL BLOOD GLUCOSE METER (K984006)Bayer Corp.1999-03-18
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 (K990394)Bio-Rad1999-03-18
ACL/APS FACS KIT (K984102)Louisville Apl Diagnostics, Inc.1999-03-18
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) (K990296)Precision Biologic1999-03-18
OSIRIS (K981153)Huestis Medical1999-03-17
SURGITRON (K990146)Ellman Intl., Inc.1999-03-17
MODIFICATION OF MOSS P.E.G. TRAY (K984628)Moss Tubes, Inc.1999-03-17
HINGED KNEE (K982160)Encore Orthopedics, Inc.1999-03-17
ULTIMAX CORTICAL BONE SCREWS (K990513)Biodynamic Technologies, Inc.1999-03-17
RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 (K984521)Richard Wolf Medical Instruments Corp.1999-03-17
ALLROUND-E (CODE NAME RD 1710) (K984587)J.F. Jelenko & Co., Inc.1999-03-17
EMOX (K984081)Emox 911 CC1999-03-17
CCD CAMERA, MODEL 9000 (K990066)Camtronics, Ltd.1999-03-17
MEDIVISION LAPAROSCOPE (K984434)Medivision Scope Service Center, Inc.1999-03-17
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM (K990481)Biodynamic Technologies, Inc.1999-03-17
CORTEX DERMASCAN C ULTRASONIC SYSTEM (K983945)Cortex Technology Aps1999-03-17
PRO2 CHECK OXYGEN INDICATOR (K983500)Medical Technology Specialists, Inc.1999-03-17
VNUS CLOSURE SYSTEM (K982816)Vnus Medical Technologies, Inc.1999-03-17
CARESIDE AST (K990009)Careside, Inc.1999-03-16
INTEGRITI PATIENT MONITOR (K980688)Alliance Instruments1999-03-16
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX (K984582)Bio-Detek, Inc.1999-03-16
IMMUNO-TROL CONTROL CELLS (K984216)Coulter Corp.1999-03-16
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 (K984466)Dilon Technologies, Inc.1999-03-16
ALADDIN II MONITORING OXYGEN/AIR MONITOR (K990293)Hamilton Medical, Inc.1999-03-16
PHILIPS NICOL COLLIMATOR FAMILY (K990423)Philips Medical Systems, Inc.1999-03-15
LOKKI DT (K980840)Hillard W. Welch1999-03-15
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER (K990152)Howmedica Osteonics Corp.1999-03-15
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER (K990805)Cordis Corp.1999-03-15
PLUS FRACTURE HEAD PROSTHESIS (K990309)Plus Orthopedics1999-03-15
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO (K990765)Flexmedics1999-03-15
BACK-ON-TRAC, MODEL 101BOT (K984190)Back-On-Track, Inc.1999-03-15
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS (K983385)Hutchison Intl., Inc.1999-03-15
HEMOSLEEVE, MODEL 4.0MM, 5.5MM (K984018)Surgical Laser Technologies, Inc.1999-03-15
TIGRAN HIP PROSTHESIS (K984492)Ponmed , Ltd.1999-03-15
BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 (K983295)Braun AG1999-03-15
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD (K990598)Howmedica Osteonics Corp.1999-03-15
MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 (K983882)Micro-Medical Devices, Inc.1999-03-15
MEDLINE EXCEL WHEELCHAIRS (K990463)Medline1999-03-15
THE BIOPLATE SHUNT CONNECTOR (K984583)Biomedics1999-03-15
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 (K990391)Bio-Rad1999-03-15
EXCELSIOR PORCELAIN SYSTEM (K984427)Ney Dental, Inc.1999-03-15
TETRAFILCON A (K990606)CooperVision, Inc.1999-03-15
PRECLUDE ACUSEAL DURA SUBSTITUTE (K984534)W. L. Gore & Associates, Inc.1999-03-15
ITI DENTAL IMPLANT SYSTEM (K983742)Institut Straumann AG1999-03-15
DRG MEDIUM SCREW SYSTEM (K990019)Dolphin Medical Technologies, Inc.1999-03-15
BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 (K983228)Murray Electronics1999-03-15
ENTERO-TEST HP, MODEL #102-01 (K983119)Hdc Corp.1999-03-15
HARWILL MEDICAL CERVITULA CERVICAL SPATULA (K983202)Harwill Medical (Pty) , Ltd.1999-03-15
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS (K981955)Ls Rubber Sdn Bhd1999-03-15
IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA (K983835)Implex Corp.1999-03-15
SILKAM NONABSORBABLE SILK SURGICAL SUTURE (K990089)Aesculap, Inc.1999-03-15
SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR (K983355)Sabratek Corp.1999-03-12
BIOSACA SYSTEM (K984580)Biosys AB (Publ)1999-03-12
IMMULITE THYROGLOBULIN MODEL LKTY (K982466)Diagnostic Products Corp.1999-03-12
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) (K982600)Wembley Rubber Products (M) Sdn Bhd1999-03-12
3D-ANGIO (K984634)Siemens Medical Corp.1999-03-12
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK (K984289)Ortho-Clinical Diagnostics, Inc.1999-03-12
SYNERGY CEMENTED HIP STEM (K990369)Smith & Nephew, Inc.1999-03-12
GYNEX ELECTRODES (K982739)Gynex Corp.1999-03-12
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS (K980964)Ls Rubber Sdn Bhd1999-03-12
IMMULITE 2000 THYROGLOBULIN MODEL L2KTY (K982468)Diagnostic Products Corp.1999-03-12
ULTRACISION HARMONIC SCALPEL HAND PIECE (K990430)Ethicon Endo-Surgery, Inc.1999-03-12
CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000 (K990049)Digident , Ltd.1999-03-12
BIOPSY-DIGIT (K990192)Sitco, Inc.1999-03-12
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (K984518)Sonic Innovations, Inc.1999-03-12
BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B (K983843)Arthrex, Inc.1999-03-12
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (K983918)Mastek, Inc.1999-03-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS (K990531)Ortho-Clinical Diagnostics, Inc.1999-03-12
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET (K984418)Medrad, Inc.1999-03-11
ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA (K990573)Estech, Inc.1999-03-11
ELECTROGLOTTOGRAPH (K990240)Kay Elemetrics Corp.1999-03-11
ZOLL M SERIES SPO2 OPTION (K982992)Zoll Medical Corp1999-03-11
MABIS NB-02 ULTRASONIC NEBULIZER (K990506)Mabis Healthcare, Inc.1999-03-11
BUZBEE (K982173)Mwr Electronics Industrial Co.1999-03-11
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT (K983927)Arterial Vascular Engineering, Inc.1999-03-11
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM (K983171)Boston Scientific Corp1999-03-11
TITANIUM FEMORAL COMPONENT (K981996)Biomet, Inc.1999-03-10
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM (K990603)Danek Medical, Inc.1999-03-10
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