Atlas FDA

1999

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

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RecordFirmDate
PE-PLUS ACETABULAR CUP (K992153)Plus Orthopedics1999-09-23
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE (K991551)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-09-23
A-18 HEMODIALYZER (K992565)Althin Medical AB1999-09-23
QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (K992849)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-09-23
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP (K990241)Accuimage Diagnostics Corp.1999-09-23
SAMSUNG RAYPAX DISPLAY WORKSTATION (K992306)Samsung Sds Co., Ltd.1999-09-22
HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 (K992609)Kay See Dental Mfg. Co.1999-09-22
ORAL SLEEP DISORDER AID (K991209)Perl-Rad Sleep Disorder Lab1999-09-22
CERADIUM NON-PRECIOUS CERAMIC ALLOY (K992705)Matech, Inc.1999-09-22
GE DIASONICS GATEWAY AND GATEWAY FX (K993069)General Electric Co.1999-09-22
AURORA HL (K992374)Premier Laser Systems, Inc.1999-09-22
CONVERTORS SURGICAL GOWNS (K992951)Allegiance Healthcare Corp.1999-09-22
AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) (K992405)Axya Medical, Inc.1999-09-22
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM (K992518)Dentsply Intl.1999-09-22
MITEK ROTATOR CUFF QUICKANCHOR PLUS (K992611)Mitek Products1999-09-22
CERANA (K992161)Nordiska Dental AB1999-09-22
SINFONY (K992645)Espe Dental AG1999-09-22
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT (K991398)Stryker Leibinger1999-09-22
BIOPRO RIMMED ACETABULAR COMPOMENT (K992144)Biologically Oriented Prostheses1999-09-22
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O (K992364)Pamitex Industries Sdn Bhd1999-09-22
NIC TONE ACRYLIC RESINS (K991577)Manufacturera Dental Continental1999-09-22
PYLON INTRAMEDULLAARY NAIL SYSTEM (K992350)Alphatec Mfg., Inc.1999-09-22
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS (K991319)Orfit Industries1999-09-21
BIOCHECK IGE ELISA, MODEL BC-1035 (K992528)Biocheck, Inc.1999-09-21
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 (K992423)Dade Behring, Inc.1999-09-21
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 (K991062)Immunetics, Inc.1999-09-21
MITEK MINI QUICKANCHOR PLUS (K992487)Mitek Products1999-09-21
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 (K991063)Immunetics, Inc.1999-09-21
ACID HEMOGLOBIN KIT (K992199)Helena Laboratories1999-09-21
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 (K992963)International Isotopes, Inc.1999-09-21
MINI-LOGGER SERIES 2000 (K991045)Mini-Mitter Co., Inc.1999-09-21
CD HORIZON SPINAL SYSTEM (K992928)Sofamor Danek USA,Inc.1999-09-21
RADIONICS MICROELECTRODE KIT (K991399)Radionics, Inc.1999-09-21
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA (K992440)Cogent Diagnotics , Ltd.1999-09-21
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN (K992296)Pasco Laboratories, Inc.1999-09-21
CANNULATED SMARTSCREW MODELS 224540C, 224570C (K992947)Bionx Implants, Ltd.1999-09-21
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 (K992763)Dade Behring, Inc.1999-09-21
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI (K992124)Avanti Polar Lipids, Inc.1999-09-20
QUICKPAC II ONE STEP COCAINE TEST (K992990)Syntron Bioresearch, Inc.1999-09-20
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 (K992559)Jostra Bentley1999-09-20
AMPLAID A724 AND A728 (K992370)Amplifon S.P.A.1999-09-20
STATVIEW SYSTEM (K990378)Data Critical Corp.1999-09-20
TOTAL HAEMOLYTIC COMPLEMENT RID KIT (K992488)The Binding Site, Ltd.1999-09-17
MEDI-TEST COMBI 11 (K991927)Macherey-Nagel-Duren1999-09-17
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 (K992670)Instrumentation Industries, Inc.1999-09-17
GAMMA-B 25-HYDROXY VITAMIN D RIA (K991998)Immunodiagnostic Systems , Ltd.1999-09-17
GILTECH PLUS HYDROGEL SKIN DRESSING (K992094)Giltech Plus, Inc.1999-09-17
LORENZ EXTERNAL MANDIBULAR DISTRACTOR (K992873)Walter Lorenz Surgical, Inc.1999-09-17
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 (K984358)Olympus America, Inc.1999-09-17
PHAZX VLD-100 (K992129)Phazx Systems, Inc.1999-09-17
CO2 GAS WARMER II, MODEL 6-800-00 (K992381)Northgate Technologies, Inc.1999-09-17
BIOBUTTON (K990194)Linvatec Corp.1999-09-17
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP (K991480)Selfcare, Inc.1999-09-17
@ TARGET (K983410)Brainlab AG1999-09-17
MODUS SYSTEM SELF-DRILLING SCREWS (K992106)Medartis AG1999-09-17
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING (K990810)Maersk Medical, Ltd.1999-09-17
CALTAG FETAL HEMOGLOBIN TEST (K990641)Caltag Laboratories, Inc.1999-09-17
COLOR BUFFED CEMENTED FEMORAL (K992903)Biomet, Inc.1999-09-17
INSTRUMENT, ULTRASONIC, SCALPEL (K990362)Ethicon Endo-Surgery, Inc.1999-09-17
FUTURA GLASS IONOMER SILVER REINFORCED (K991974)Ab Ardent1999-09-17
CARDIOPHONICS 1000 MEMORY MONITOR (K992772)Rlt Medical Assoc., Inc.1999-09-17
TENS/FES/NMES ELECTRODES (K983097)Uni-Patch, Inc.1999-09-17
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K992321)Dade Behring, Inc.1999-09-17
DRX QT. HCG (K991532)Metrika, Inc.1999-09-17
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE (K992839)Heinz Kurz GmbH Medizintechnik1999-09-16
ECHOFLOW DOPPLER BLOOD VELOCITY METER (K990642)Echocath, Inc.1999-09-16
BEAR CUB 750 PSV (K992788)Bear Medical Systems, Inc.1999-09-16
BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM (K983717)Aerotel Medical Systems (1998) , Ltd.1999-09-16
STEPPING KINEMATIC IMAGING PLATFORM (SKIP) (K992892)Magnetic Moments, LLC1999-09-16
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN) (K992143)Pasco Laboratories, Inc.1999-09-16
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573)Alcon Laboratories1999-09-16
FRESH AIR (K981047)Colorado Medtech, Inc.1999-09-16
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K992399)Bayer Corp.1999-09-15
CYNOSURE ACCOLADE LASER (K992814)Cynosure, Inc.1999-09-15
CARESIDE CO2, TOTAL (K992475)Careside, Inc.1999-09-15
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) (K992910)Medtronic Vascular1999-09-15
CORDIS EXTREME PTA BALLOON CATHETER (K992825)Cordis Corp.1999-09-15
NAC PRN NEEDLELESS ACCESS CONNECTOR (K992268)The Kipp Group1999-09-15
BOLUS ACCESSORY SET (K992072)I-Flow Corp.1999-09-15
NUCLISENS CMV PP67 (K983762)Organon Teknika Corp.1999-09-15
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196)Tz Medical, Inc.1999-09-15
REDI-TEST OPIATES (K991883)Advantage Diagnostics Corp.1999-09-15
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE (K992755)Cordis, A Johnson & Johnson Co.1999-09-15
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232)Tz Medical, Inc.1999-09-15
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES (K991125)Sauflon Pharmaceuticals, Ltd.1999-09-14
SCHOELLY RIGID ENDOSCOPES (K992437)Fiber Imaging Technologies, Inc.1999-09-14
LUMENON XENON LIGHT SOURCE (K992050)Walter Lorenz Surgical, Inc.1999-09-14
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 (K990212)Doctor'S Research Group, Inc.1999-09-14
HELICA TC (K972267)Tenerco, Inc.1999-09-14
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS (K992128)Dash Medical Gloves Sdn Bhd1999-09-14
MADTRONIC DLP ARTERIAL CANNULAE (K991066)Medtronic Vascular1999-09-14
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992464)Shijiazhuang Dilly Plastics Products Co., Ltd.1999-09-14
PREMIER ANTERIOR CERVICAL PLATE SYSTEM (K992110)Sofamor Danek USA1999-09-14
AEROCHAMBER PLUS VALVED HOLDING CHAMBER (K992917)Trudell Medical Int'L1999-09-14
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI (K991419)Irvine Scientific Sales Co., Inc.1999-09-14
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I (K992807)Bio-Logic Systems Corp.1999-09-14
HYDROFERA BACTERISTATIC NASAL DRESSING (K983276)Hydrofera, LLC1999-09-14
CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 (K991529)Conway Stuart Medical, Inc.1999-09-14
DANEK PLATE AND SCREW SYSTEM (K991036)Sofamor Danek USA,Inc.1999-09-14
CONTROL III ELITE (K992661)Maril Products, Inc.1999-09-14
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