Atlas FDA

1999

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

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RecordFirmDate
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH (K982283)Caradyne, Ltd.1999-03-09
OSOM CARD II HCG-URINE TEST, MODEL 102 (K990578)Wyntek Diagnostics, Inc.1999-03-09
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 (K990282)Bio-Rad1999-03-09
WAKO AUTOKIT LP(A) (K981446)Wako Chemicals USA, Inc.1999-03-09
GTI-PF4 ELISA (K983379)Genetic Testing Institute1999-03-09
GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K984608)Oxoid , Ltd.1999-03-09
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 (K990375)Medtronic Functional Diagnostics A/S1999-03-09
OSOM CARD PREGNANCY TEST, MODEL 103 (K990576)Wyntek Diagnostics, Inc.1999-03-09
LC FLOWFILL (K990108)S & C Polymer GmbH1999-03-09
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR (K990453)Alliance Rubber Products Sdn. Bhd.1999-03-09
SYSTEM U3 FOR CEFUROXIME (K984491)Ab Biodisk1999-03-09
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 (K984271)Medtronic Vascular1999-03-09
SYSTEM U3 FOR CEPHALOTHIN (K984581)Ab Biodisk1999-03-09
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR (K990514)C.R. Bard, Inc.1999-03-09
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K990283)Hartalega Sdn Bhd1999-03-09
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING (K984394)Guidant Corp.1999-03-08
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (K983126)Minntech Corp.1999-03-08
RF (K990035)Abbott Laboratories1999-03-08
OPTIBOND SOLO PLUS (K990498)Sybron Dental Specialties, Inc.1999-03-08
CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 (K983105)Dentsply Midwest1999-03-08
COOL-TIP RF SYSTEM (K984552)Radionics, Inc.1999-03-05
AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 (K981702)Nihon Seimitsu Sokki Co., Ltd.1999-03-05
EXMOOR SUCTION CLEARANCE KIT (K990366)Exmoor Plastics , Ltd.1999-03-05
SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM (K984602)Syntec Scientific Corp.1999-03-05
ACCU GUIDE (K984382)Tayman Medical, Inc.1999-03-05
MULTITAK SS BUTTONS (K990156)Bonutti Research1999-03-05
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX (K984607)Richard Wolf Medical Instruments Corp.1999-03-05
MAXIM REMOVABLE MOLDED POLY TIBIA (K984623)Biomet, Inc.1999-03-05
AURA DYE LASER SYSTEM (ADLS) (K984424)Laserscope1999-03-05
BONE ANCHOR SYSTEM III (BAS III) (K990295)Boston Scientific Corp1999-03-05
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT (K980351)Boston Biomedica, Inc.1999-03-05
ORBSCAN (K984443)Technolas Perfect Vision GmbH1999-03-05
IMFAST (K982952)Siemens Medical Solutions USA, Inc.1999-03-05
SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) (K983194)Sporicidin Intl.1999-03-05
RESTORE (AKA RE/STOR) (K983164)Nebl, Inc.1999-03-05
AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR (K984352)Aaron Medical Industries1999-03-04
EBV-VCA IGG ELISA TEST SYSTEM (K981812)Diamedix Corp.1999-03-04
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII (K990326)Radionics Software Applications, Inc.1999-03-04
LIGHTSHEER LONG PULSE RUBY LASER (K982980)Palomar Medical Products, Inc.1999-03-04
MONOPAQUE (K990315)Ivoclar North America, Inc.1999-03-04
ALLISON MEDICAL INSULIN SYRINGE (AMIS) (K984017)Allison Medical, Inc.1999-03-04
NERVE BLOCK INFUSION KIT (K984502)I-Flow Corp.1999-03-04
NATURAL BRAND ACUPUNCTURE NEEDLES (K983671)Tcm Supply Corp.1999-03-04
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES (K990379)Dexide, Inc.1999-03-04
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K983071)Respironics, Inc.1999-03-04
TRANSFX EXTERNAL FIXATION SYSTEM (K984357)Immedica, Inc.1999-03-04
POLYMER OBL SB ANCHOR / SUTURE COMBINATION (K982996)Orthopaedic Biosystems, Ltd.1999-03-04
VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES (K984596)Zymetx, Inc.1999-03-04
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 (K990306)Kay See Dental Mfg. Co.1999-03-03
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280 (K981431)Panasonic Corporation (Panasonic)1999-03-03
STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) (K981947)Boston Medical Corp.1999-03-03
TOPOGRAPHIC IMAGING MARKER (K990298)I.Z.I. Medical Products Corp.1999-03-03
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 (K983075)Guidant Corp.1999-03-03
HA ABSORBENT WOUND DRESSING (K984388)Convatec, A Division of E.R. Squibb & Sons1999-03-03
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 (K981542)Panasonic Corporation (Panasonic)1999-03-03
TOPOGRAPHIC IMAGING MARKER (K990242)I.Z.I. Medical Products Corp.1999-03-03
MEPITEL NON ADHERENT SILICONE DRESSING (K984371)Molnlycke Health Care, Inc.1999-03-03
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM (K983797)Dutch Ophthalmic USA, Inc.1999-03-03
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 (K984364)Syntec Scientific Corp.1999-03-02
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE (K990131)Interpore Cross Intl.1999-03-02
PHORESOR II,MODEL PM900 (K982668)Iomed, Inc.1999-03-02
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR (K984322)Dideco S.P.A.1999-03-02
MOSS TUBES, INC. NASAL TUBE - MARK IV (K984629)Moss Tubes, Inc.1999-03-02
SSA-320A JUST VISION 200/ SSA-325A JUST VISION (K990490)Toshiba America Medical Systems, In.C1999-03-02
ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL (K964235)Industrielle Entwicklung Medizintechnik Und Vertri1999-03-02
MODIFICATION OF CUTINOVA CAVITY DRESSING (K984597)Beiersdorf-Jobt, Inc.1999-03-01
SUTURELESS ANCHOR (K984490)Innovasive Devices, Inc.1999-03-01
D-SIGN VI (R&D PROJECT DW266#9) (K990235)Ivoclar North America, Inc.1999-03-01
HYPERGEL 20% HYPERTONIC SALINE GEL (K984370)Molnlycke Health Care, Inc.1999-03-01
MODIFICATION OF CUTINOVA HYDRO DRESSING (K984595)Beiersdorf-Jobt, Inc.1999-03-01
MODIFICATION OF CUTINOVA FOAM DRESSING (K984599)Beiersdorf-Jobt, Inc.1999-03-01
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) (K982738)Gynecare, Inc.1999-03-01
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) (K983817)King Systems Corp.1999-03-01
PROVISIONAL DENTAL IMPLANT SYSTEM (K984287)Nobel Biocare Uas, Inc.1999-03-01
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE (K983790)Sun Biomedical Laboratories, Inc.1999-03-01
D-SIGN V (R&D PROJECT DW267#17) (K990182)Ivoclar North America, Inc.1999-03-01
ANATOMICA GLENOID COMPONENT (K990136)Sulzer Orthopedics, Inc.1999-03-01
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING (K984539)Ferris Mfg. Corp.1999-03-01
`THE INSEMINATOR' (PROPOSED) (K984306)Wallach Surgical Devices, Inc.1999-03-01
TUTODROP 1 AND TUTODROP 2 (K982098)Myco Medical Supplies, Inc.1999-03-01
MODIFICATION OF CUTINOVA THIN DRESSING (K984593)Beiersdorf-Jobt, Inc.1999-03-01
FIXATION SYSTEM (K983318)General Surgical Innovations1999-03-01
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES (K983476)Navion Biomedical Corp.1999-03-01
SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 (K984543)Syntec Scientific Corp.1999-03-01
PRE-THREADED ENDOBUTTON (K984550)Smith & Nephew, Inc.1999-03-01
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES (K990106)Bio-Detek, Inc.1999-02-26
DIOSCAN (K990014)Diomed, Inc.1999-02-26
ARTHRO-SURGIMAT-2000 ECU (K990443)W.O.M. World of Medicine GmbH1999-02-26
7F HYDROLYSER THROMBECTOMY CATHETER (K983534)Cordis Corp.1999-02-26
MTM BIOSCANNER K TEST STRIPS (K981865)Polymer Technology Systems, Inc.1999-02-26
CROSS SPORT, RIGID WHEELCHAIR (K990358)Tisport1999-02-26
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 (K984503)Wallace A. Erickson & Co.1999-02-26
STIMULAN- CALCIUM SULFATE BONE VOID FILLER (K982663)Encore Orthopedics, Inc.1999-02-26
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM (K984363)Xomed, Inc.1999-02-26
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP (K983204)Harwill Medical (Pty) , Ltd.1999-02-26
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984558)Ansell Perry1999-02-26
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST (K984525)American Bio Medica Corp.1999-02-26
HSV 1+2 IGG ELISA TEST (K983541)Gull Laboratories, Inc.1999-02-26
ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984559)Ansell Perry1999-02-26
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 (K981125)Medical Components, Inc.1999-02-26
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