Atlas FDA

1999

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

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RecordFirmDate
AMPLAID A315 AND A319 (K983915)Amplifon S.P.A.1999-01-29
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM (K982346)AngioDynamics, Inc.1999-01-29
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K990026)Ortho-Clinical Diagnostics, Inc.1999-01-29
SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES (K983858)Sims Portex, Inc.1999-01-29
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K (K990125)Hewlett-Packard GmbH1999-01-29
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN (K983966)Dentsply Intl.1999-01-29
APOLIPOPROTEIN A1 (K983289)Abbott Laboratories1999-01-29
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 (K984626)Bio-Rad1999-01-29
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS (K984055)Sims Deltec, Inc.1999-01-29
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS (K983674)Ortho-Clinical Diagnostics, Inc.1999-01-29
OPMI TWINER SURGICAL MICROSCOPE (K983868)Carl Zeiss, Inc.1999-01-29
DCI ENDOSCOPE (K984369)KARL STORZ Endoscopy-America, Inc.1999-01-29
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402)Beckman Coulter, Inc.1999-01-29
VENOMETER (K983900)Advanced Medical Technology , Ltd.1999-01-29
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT (K984152)Beckman Coulter, Inc.1999-01-29
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982328)Bayer Corp.1999-01-29
POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 (K983029)Tpc Advanced Technology, Inc.1999-01-29
EXHALATION VALVE (K984481)Intersurgical, Inc.1999-01-29
PHILIPS EASYGUIDE (K981480)Philips Medical Systems, Inc.1999-01-28
DEPUY PROFILE FEMORAL HIP WITH POROCOAT (K984459)DePuy Orthopaedics, Inc.1999-01-28
COMPEED PSORIASIS DRESSING (K982493)Coloplast Corp.1999-01-28
MECHANICAL WHEELCHAIR (K984354)Colours 'N Motion1999-01-28
CAPELLA COCHLEAR EMISSIONS ANALYZER (K983851)Madsen Electronics, Inc.1999-01-28
P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY (K984158)Depuy, Inc.1999-01-28
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303)Ortho-Clinical Diagnostics, Inc.1999-01-28
HEMOCHEK SAMPLE COLLECTION KIT (K984529)Osborn Laboratories, Inc.1999-01-28
AUTOSTAT II ANA SCREEN ELISA (K983655)Cogent Diagnotics , Ltd.1999-01-28
MS300 (K984021)Lsi Intl., Inc.1999-01-28
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 (K990162)Bio-Rad1999-01-28
ASKINA HYDROCOLLOID/THIN (K973227)B.Braun Medical, Inc.1999-01-28
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 (K990161)Bio-Rad1999-01-28
ACTIVX (K984367)Adorno Rogers Technology1999-01-28
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 (K984132)Diagnostic Products Corp.1999-01-28
INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER (K983560)Innovasive Devices, Inc.1999-01-28
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (K982634)Oxoid , Ltd.1999-01-28
BIRCOLL BALLOON DISSECTOR (K984448)Wells Johnson Co.1999-01-28
UALB (K983774)Abbott Laboratories1999-01-28
RDI DIRECT LDL CHOLESTEROL TEST (K984107)Reference Diagnostics, Inc.1999-01-28
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA (K984137)Inova Diagnostics, Inc.1999-01-28
MS400 (K984113)Lsi Intl., Inc.1999-01-28
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS (K983592)Sulzer Orthopedics, Inc.1999-01-28
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET (K984082)Emox 911 CC1999-01-28
IS-RUBELLA IGG TEST SYSTEM (K981729)Diamedix Corp.1999-01-28
BIOABSORBABLE INTERFERENCE SCREWS (K984320)Smith & Nephew, Inc.1999-01-28
BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 (K983852)Geiger Medical Technologies, Inc.1999-01-28
CD HORIZON SPINAL SYSTEM (K981676)Sofamor Danek USA,Inc.1999-01-28
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS (K990059)Howmedica Osteonics Corp.1999-01-28
ENDIUS SPINE ENDOSCOPE (K982819)Endius, Inc.1999-01-27
LACTOSORB MENISCAL REPAIR DEVICE (K982095)Biomet, Inc.1999-01-27
KAVO KEY LASER 1242 (K983100)Kavo America1999-01-27
CHAIT CECOSTOMY CATHETER (K982500)Cook, Inc.1999-01-27
VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM (K982506)Cryosurgery, Inc.1999-01-27
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (K972616)Wembley Rubber Products (M) Sdn Bhd1999-01-27
MERCATOR (K982384)Harley Street Software , Ltd.1999-01-27
INVACARE CPAP (K982242)Invacare Corp.1999-01-27
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, (K982540)Cardiac Pathways Corp.1999-01-27
AURORA (K972065)Neurovena Corp.1999-01-27
GT LEGGIERO (K981359)Terumo Medical Corp.1999-01-27
SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE (K983988)Syntec Scientific Corp.1999-01-27
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) (K984260)Terumo Medical Corp.1999-01-26
PLANMECA INTRACAM STATION (K984013)Planmeca Oy1999-01-26
BICON BONE SCREW SYSTEM (K982488)Bicon, Inc.1999-01-26
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 (K990150)Bio-Rad1999-01-26
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL (K983799)Medtronic PS Medical1999-01-26
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY (K983992)Nichols Institute Diagnostics1999-01-26
KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR (K983809)KLS-Martin L.P.1999-01-26
VITROS CHEMISTRY PRODUCTS PHBR SLIDES (K984288)Ortho-Clinical Diagnostics, Inc.1999-01-26
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) (K972615)Wembley Rubber Products (M) Sdn Bhd1999-01-26
VAGABOND SOFT RESTRAINT SYSTEM (K982178)Emergent Innovations, Ltd.1999-01-26
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM (K982090)Paceart, Inc.1999-01-26
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 (K990149)Bio-Rad1999-01-26
APOB (K983281)Abbott Laboratories1999-01-26
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K983145)Shen Wei (Usa), Inc.1999-01-26
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER (K983912)Vistakon, Johnson & Johnson Vision Products, Inc.1999-01-26
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER (K983832)Idem (Int'L Dist. of Electronics For Medicine)1999-01-25
VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS (K981954)Healthline Implants, Inc.1999-01-25
ENTAXIS NASAL PACKING (K984069)Les Laboratorires Brothier, S.A.1999-01-25
MEDRAD PHASED ARRAY NEUROVASCULAR COIL (K984257)Medrad, Inc.1999-01-25
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 (K990017)Bio-Rad1999-01-25
IMATION TRIMATIC DIGITAL SYSTEM (K984252)Imation Corp.1999-01-25
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS (K990061)Ortho-Clinical Diagnostics, Inc.1999-01-25
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 (K982264)Survivalink Corp.1999-01-25
BLADDERMANAGER PCI 5000 MODEL 1002 (K982568)Diagnostic Ultrasound Corp.1999-01-25
ELECTROSURGICAL DISPERSIVE ELECTRODE (K983782)Conmedcorp1999-01-25
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS (K984273)Ciba Vision Corporation1999-01-25
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE (K984274)Hitachi Medical Systems America, Inc.1999-01-25
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K984127)Kilang Barangan Getah Dioh1999-01-25
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) (K984605)Perusahaan Getah Asas Sdn. Bhd.1999-01-25
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- (K982432)Tinnitus Treatment Centers, Inc.1999-01-25
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 (K983905)Eastman Kodak Company1999-01-25
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS (K984045)Kamiya Biomedical Co.1999-01-25
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY (K984232)Syva Co.1999-01-22
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F (K984317)Zeus Scientific, Inc.1999-01-22
DRAGER OXYLOG 2000 (K984577)Drager, Inc.1999-01-22
6004 NIBP MONITOR WITH TEMPERATURE (K983796)Bci Intl., Inc.1999-01-22
EMS PEEP VALVES- ADJUSTABLE (K983920)Engineered Medical Systems1999-01-22
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM (K984181)Zeus Scientific, Inc.1999-01-22
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS (K984321)Ortho-Clinical Diagnostics, Inc.1999-01-22
ALLEGIANCE PORTA-WARM MATTRESS (K982652)Allegiance Healthcare Corp.1999-01-21
TELEX TINNITUS-COMPANION (K984243)Telex Communications, Inc.1999-01-21
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