Atlas FDA

1999

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

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RecordFirmDate
HAMILTON MEDICAL GALILEOVENTILATOR (K982910)Hamilton Medical, Inc.1999-09-14
XENON LIGHT SOURCE PES 1 (K992540)Laser Optik Systeme GmbH & Co. KG1999-09-14
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K992171)Allegiance Healthcare Corp.1999-09-14
QUALATEX POWDERED LATEX EXAMINATION GLOVES (K992557)Tan Sin Lian Industries Sdn. Bhd.1999-09-14
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE (K992730)Hwa Teh Industrial Sdn. Bhd.1999-09-14
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (K992302)Dermaphylyx, Inc.1999-09-14
COLLINS CPL (K992743)Collins Medical, Inc.1999-09-13
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 (K992308)Lifetek Medical, Inc.1999-09-13
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR (K992417)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC (K992311)Kamiya Biomedical Co.1999-09-13
KION ANESTHESIA SYSTEM (K973971)Siemens Medical Solutions USA, Inc.1999-09-13
BIO-MODULAR SHOULDER SYSTEM (K992119)Biomet, Inc.1999-09-13
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER (K992307)Fertility Technology Resources, Inc.1999-09-13
SAMSUNG RAYPAX LONG TERM ARCHIVE (K992131)Samsung Sds Co., Ltd.1999-09-13
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP (K992803)Sigma Diagnostics, Inc.1999-09-13
ENDO-SPOR PLUS / HYPROCIDE (K972708)Cottrell, Ltd.1999-09-13
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M (K991388)Pacific Andrology, Inc.1999-09-13
ORATEC BIPOLAR ABLATION PROBES (K991218)Oratec Interventions, Inc.1999-09-13
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR (K992419)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO (K991799)Davol Inc., Sub. C. R. Bard, Inc.1999-09-13
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B (K992312)Kamiya Biomedical Co.1999-09-13
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 (K992057)Sims Portex, Inc.1999-09-13
CORTICAL MAPPING UNIT, MODEL CMU (K992194)Ad-Tech Medical Instrument Corp1999-09-13
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI (K992418)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (K992694)Myotronics-Noromed, Inc.1999-09-10
FREEDOM INFUSION SYSTEM (K992015)Novacon Corp.1999-09-10
DUPEL IONTOPHORESIS SYSTEM (K991991)Empi1999-09-10
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE (K992588)Formosa Glove Industrial Co., Ltd.1999-09-10
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES (K992210)Safeskin Corp.1999-09-10
SYNEA-HS HIGH SPEED-HANDPIECE (K992011)A-Dec, Inc.1999-09-10
BARD BALLOON INFLATION SYSTEM (K991375)C.R. Bard, Inc.1999-09-10
TWILIGHT (K991994)Biolase Technology, Inc.1999-09-10
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE) (K992358)Biopro (M) Sdn Bhd1999-09-10
CHRISTOUDIAS SLIM TIP ELECTRODE INSERT (K992345)Innervision, Inc.1999-09-10
THERMALIGHT 2000 (K992630)Jennifermaxx, Inc.1999-09-10
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) (K992196)Hemocleanse, Inc.1999-09-10
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE (K992721)Radionics, Inc.1999-09-10
TRI-POLAR SYSTEM (K991990)Biomet, Inc.1999-09-10
RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 (K992693)Rita Medical Systems1999-09-10
<GEN>SINGLE LUMEN NEEDLE (K991262)<Genx> Intl., Inc.1999-09-09
<GENX> SINGLE LUMEN SIDEPORT NEEDLE (K991264)<Genx> Intl., Inc.1999-09-09
KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR (K992027)Karl Storz Endoscopy1999-09-09
SAMSUNG RAYPAX FILM DIGITIZER (K992112)Samsung Sds Co., Ltd.1999-09-09
TERUMO U-100 INSULIN SYRINGE (K992802)Terumo Medical Corp.1999-09-09
<GENX> DOUBLE LUMEN NEEDLE (K991020)<Genx> Intl., Inc.1999-09-09
MEDTRONIC GT2 FUSION GUIDE WIRES (K992237)Medtronic Vascular1999-09-09
PHILIPS EASYVISION WORKSTATION: (K990335)Philips Medical Systems North America, Inc.1999-09-09
PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 (K992091)Bio-Plexus, Inc.1999-09-09
AX WORKSTATION (K992073)Siemens Medical Solutions USA, Inc.1999-09-09
<GENX> SPERM WASHING MEDIA (K991022)<Genx> Intl., Inc.1999-09-09
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS) (K991969)Pamitex Industries Sdn Bhd1999-09-09
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834)Cholestech Corp.1999-09-09
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION (K991986)Cobe Cardiovascular, Inc.1999-09-09
<GENX> EMBRYO TRANSFER CATHETER CC GLIDER (K991266)<Genx> Intl., Inc.1999-09-09
POCKETSPACER (K992038)Ferraris Medical, Inc.1999-09-09
RENDER-PLAN 3-D (K992864)Precision Therapy Intl., Inc.1999-09-09
IMPREGUM PENTA (K992897)Espe Dental AG1999-09-08
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 (K992305)Medi-Stim A/S1999-09-08
ECHOCARDIOGRAPHY SYSTEM SERIES 95000 (K992259)Camtronics, Ltd.1999-09-08
CYNOSURE DIODERM (K992765)Cynosure, Inc.1999-09-08
IMPREGUM F (K992895)Espe Dental AG1999-09-08
GO GLUCOSE MONITORING SYSTEM (K991754)Lxn Corp.1999-09-08
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM (K992135)Ge Medical Systems, Inc.1999-09-08
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR (K991996)Denplus, Inc.1999-09-08
DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER (K992013)Continuum Biomedical, Inc.1999-09-08
SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS (K992640)Minumys Surgical, Inc.1999-09-08
MILLENNIUM GOLD (K992090)Skytron, Div. the Kmw Group, Inc.1999-09-08
INFUSION DYNAMICS POWER INFUSER MODEL M100B (K992044)Infusion Dynamics, Inc.1999-09-08
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER (K992379)Radionics, Inc.1999-09-08
SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM (K992472)Clinicon Corp.1999-09-08
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE (K992893)Mrlb Intl., Inc.1999-09-08
PTFE RINGED GORE-TEX VASCULAR GRAFT (K991683)W. L. Gore & Associates, Inc.1999-09-08
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K992170)Best Manufacturing Company1999-09-07
QUANTITATIVE FLOW (K992225)Philips Medical Systems (Cleveland), Inc.1999-09-07
BIO-97 (K991901)Jeneric/Pentron, Inc.1999-09-07
GENDEX 765DC, MODEL 110-0154 (K992610)Dentsply Intl.1999-09-07
DENTAPURE DP40 CARTRIDGE (K992868)Mrlb Intl., Inc.1999-09-07
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY (K992063)Howmedica Osteonics Corp.1999-09-03
ENDO-ESOPHAGEAL MR COIL (K992193)Surgi-Vision, Inc.1999-09-03
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM (K992753)Varian Assoc., Inc.1999-09-03
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) (K992896)Dental X-Ray Support Systems, Inc.1999-09-03
MUMPS IGG ELISA TEST SYSTEM (K991274)Columbia Bioscience, Inc.1999-09-03
URINE CHEMISTRY CONTROL, LEVEL 1 (K992576)Consolidated Technologies, Inc.1999-09-03
STECO-TITANMAGNETICS (K990979)Steco-System-Technik GmbH & Cokg1999-09-03
CAPIOX SX10 HARDSHELL RESEVOIR (K991973)Terumo Medical Corp.1999-09-03
ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L (K991946)Sterilex Corp.1999-09-03
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (K990762)Zoll Medical Corp1999-09-03
PRISMATHERM II, ASTOLINE (K991159)Stihler Electronic GmbH1999-09-03
GILTECH PLUS TRANSPARENT DRESSING (K992005)Giltech Plus, Inc.1999-09-03
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K992677)Hologic, Inc.1999-09-03
PASCO MIC AND MIC/ID PANELS (CEFEPIME) (K992108)Pasco Laboratories, Inc.1999-09-03
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER (K980024)Shining World Health Care Co., Ltd.1999-09-03
MODULAR RADIAL HEAD (K991915)Wrightmedicaltechnologyinc1999-09-03
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN (K992297)Pasco Laboratories, Inc.1999-09-03
URINE CHEMISTRY CONTROL, LEVEL 2 (K992578)Consolidated Technologies, Inc.1999-09-03
STACKABLE CAGE SYSTEM (K990148)Depuy Motech Acromed1999-09-03
THE LIBERATOR (K984391)Liberator Wheelchairs, Inc.1999-09-03
THE NOMOS CHANE II (K991966)Nomos Corp.1999-09-03
FRESENIUS BLOOD VOLUME MONITOR (K982926)Fresenius Medical Care North America1999-09-03
PASCO MIC AND MIC/ID PANELS (OFLOXACIN) (K992077)Pasco Laboratories, Inc.1999-09-03
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