Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
QUICKPAC II ONE STEP BARBITURATE TEST (K980349)Syntron Bioresearch, Inc.1998-03-03
SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) (K974555)Synthes (Usa)1998-03-03
PREPQUICK (K974786)Ultradent Products, Inc.1998-03-03
PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO (K980381)Carmel Pharma Ab.1998-03-03
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT (K974084)Getinge/Castle, Inc.1998-03-03
ACCUSTAT H. PYLORI ONE STEP TEST (K973523)Boehringer Mannheim Corp.1998-03-03
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K974721)Bayer Corp.1998-03-03
IMTEC/BIOBARRIER MEMBRANE (K974752)Imtec Corp.1998-03-03
PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE (K962903)Prestige Medical Corp.1998-03-03
IS-DSDNA TEST SYSTEM (K974694)Diamedix Corp.1998-03-03
MENISCAL REPAIR DEVICE (K974538)Linvatec Corp.1998-03-03
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) (K980528)Chiron Diagnostics Corp.1998-03-03
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (K980141)Spectrum Designs, Inc.1998-03-03
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET (K980414)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-03-03
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (K980140)Spectrum Designs, Inc.1998-03-03
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (K980032)Diagnostic Chemicals , Ltd.1998-03-02
ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS) (K974599)Opti-Centre Laboratories1998-03-02
HYDROFERA SURGICAL SPEAR (K974313)Hydrofera, LLC1998-03-02
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 (K974475)Biocontrol Technology, Inc.1998-03-02
LEKSELL STEREOTACTIC SYSTEM (K972324)Elekta Instrument AB1998-03-02
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER (K971759)Green Field Medical Sourcing, Inc.1998-03-02
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT (K974724)Lens Comfort, Inc.1998-03-02
COLPO CUP CVC-2000 (K974563)Clinical Innovations, Inc.1998-03-02
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (K973108)Diagnostic Chemicals , Ltd.1998-03-02
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED (K971028)Worlds-Best Gummivarefabrik A/S1998-03-02
PORTABLE INTENSIVE CARE UNIT (K974034)Medical Research Laboratories, Inc.1998-03-02
SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM (K974525)Synthes Spine1998-03-02
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER (K980061)Rocket Medical Plc1998-03-02
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN (K973357)Zimmer, Inc.1998-03-02
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE (K980093)Universal Gloves Corp.1998-03-02
NT2000 (K972244)Bio-Medical Research, Ltd.1998-02-27
AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 (K980366)Aaron Medical Industries1998-02-27
S3 MAST PUMP (K972321)Stoeckert Instrumente1998-02-27
FIRE STICK (K973197)H.S. Intl. Co., Inc.1998-02-27
FASTDAM (K972775)Interdent, Inc.1998-02-27
LSF HA COATED TRIAD TOTAL HIP SYSTEM (K974506)Osteoimplant Technology, Inc.1998-02-27
MSB TENS ELECTRODES (DISPOSABLE) (K980229)Msb , Ltd.1998-02-27
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE (K974082)Performance Plus, Inc.1998-02-27
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS (K973409)Davis & Geck, Inc.1998-02-27
MICROFUSE MEMBRANE INFUSION CATHETER (K971619)E-Med Corp.1998-02-27
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE (K974067)Merit Medical Systems, Inc.1998-02-27
DERMASENSE PLUS DISPERSIVE ELECTRODE (K980171)Horizon Medical, Inc.1998-02-27
EPS (K974504)E For M Imaging Systems Div., Marquette Electronic1998-02-27
MENTOR SKIN PROTECTION PAD (K980050)Mentor Corp.1998-02-27
PERITONEAL DIALYSIS CATHETER CONNECTOR (K974570)Medigroup, Inc.1998-02-27
KSEA ENDOTIP SYSTEM (K973909)KARL STORZ Endoscopy-America, Inc.1998-02-27
WELCH ALLYN XENON 300 LIGHT SOURCE (K980281)Welch Allyn, Inc.1998-02-27
4.0MM SIMPLER THREADED DENTAL IMPLANT (K974857)Vancouver Implant Resources, Inc.1998-02-27
SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS (K980156)Surgical Laser Technologies, Inc.1998-02-27
CYNOSURE PHOTOGENICA 532 LASER (K974900)Cynosure, Inc.1998-02-27
3.25MM SIMPLER THREADED DENTAL IMPLANT (K974856)Vancouver Implant Resources, Inc.1998-02-27
ULTRACON ULTRAFILTRATOR (K971710)Quantic Biomedical, Inc.1998-02-27
BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER (K980418)Benz Research and Development Corp.1998-02-27
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM (K973425)Corin USA1998-02-27
BIOSCREW ABSORBABLE INTERFERENCE SREW (K973758)Linvatec Corp.1998-02-27
FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM (K971348)Green Field Medical Sourcing, Inc.1998-02-27
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM (K974556)Osteonics Corp.1998-02-27
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS (K974492)Siemens Medical Solutions USA, Inc.1998-02-26
ULTRASAFE MODEL T200 INJECTOR (K972900)Safety Syringes, Inc.1998-02-26
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM (K973000)Alimenterics, Inc.1998-02-26
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT (K971593)The Silcraft Corp.1998-02-26
INTROSYTE CATHETER (K974764)Becton Dickinson Infusion Therapy Systems, Inc.1998-02-26
NEUROAMP EEG AMPLIFIER (K974495)Neurocorp, Ltd.1998-02-26
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM (K971592)The Silcraft Corp.1998-02-26
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (K980509)Deroyal Industries, Inc.1998-02-26
PREVENT I (K973373)The Buzzz Corp.1998-02-26
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (K972883)Cypress Medical Products, Ltd.1998-02-26
PROMAX SURGICAL DRAPES AND COVERS (K980183)Standard Textile Co., Inc.1998-02-26
STRATIS II (K974498)Hitachi Medical Systems America, Inc.1998-02-26
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD (K972877)Safety Syringes, Inc.1998-02-26
D/SENSE-T (K973285)Centrix, Inc.1998-02-25
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE (K974710)Sinochem Ningbo Latex Gloves Factory1998-02-25
LIQUICHEK CARDIAC MARKERS CONTROL LT (K980556)Bio-Rad1998-02-25
READYCATH CATHETER (K973120)Medical Technologies of Georgia1998-02-25
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM (K974619)Afp Imaging Corp.1998-02-25
VITROS CHEMISTRY PRODUCTS CRBM SLIDES (K980283)Johnson & Johnson Clinical Diagnostics, Inc.1998-02-25
ERECAID SYSTEM/STAY EREC SYSTEM (K974173)Imagyn Medical Technologies, Inc.1998-02-25
VOICE MASTER PROSTHESIS (K974132)E. Benson Hood Lab, Inc.1998-02-25
ECAT PET SCANNERS (K974256)Cti Pet Systems, Inc.1998-02-25
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST (K973269)Drial Consultants, Inc.1998-02-25
BPX80 BIO-PUMP (BPX80) (K973011)Medtronic Bio-Medicus, Inc.1998-02-25
ECHOLINK (K980060)Mpacs, LLC1998-02-25
3D I-SCAN (K974522)Ophthalmic Technologies, Inc.1998-02-25
CPD COMMANDER (K974253)Scieran Technologies, Inc.1998-02-25
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT (K974658)Phonic Ear, Inc.1998-02-25
CREATINE KINASE REAGENT (K980012)Ac Biochemicals, Inc.1998-02-25
STERI-TAMP (K974180)Pharmacy, Inc.1998-02-24
CLEARFIL DC CEMENT (K980232)Kuraray Company, Ltd.1998-02-24
SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION (K974485)Szabocsik and Assoc.1998-02-24
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS (K980490)Sage Products, Inc.1998-02-24
VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (K972075)Becton Dickinson Vacutainer Systems1998-02-24
SILIMED CALF IMPLANT (K974480)Silimed, LLC1998-02-24
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (K972145)Immuno Concepts, Inc.1998-02-24
TESTOTERONE ELISA (K973900)Kmi Diagnostics, Inc.1998-02-24
DYNEMO 3000 (K972798)Sometec, Inc.1998-02-24
SILIMED GLUTEAL IMPLANT (K974482)Silimed, LLC1998-02-24
SYNERMED CREATININE REAGENT KIT (K974909)Synermed Intl., Inc.1998-02-24
GLENROE CHAIN (K980053)Glenroe Technologies1998-02-24
PEGASYS INTOUCH (K974474)Adac Laboratories1998-02-24
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K980466)Sims Portex, Inc.1998-02-24
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