Atlas FDA

2004

3,373 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE (K033994)Novabone Products, LLC2004-03-25
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) (K040694)Micro Therapeutics, Inc.2004-03-25
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (K031176)Invacare Corp.2004-03-25
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL (K040670)Home Diagnostics, Inc.2004-03-25
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM (K040628)Abbott Laboratories2004-03-25
RAPID PROGRAMMER (K040609)Advanced Neuromodulation Systems2004-03-25
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET (K040226)Wako Chemicals USA, Inc.2004-03-25
HEMORRHAGE OCCLUDER PIN (K040109)Tools For Surgery, LLC2004-03-25
TENDERWET ACTIVE (K040517)Medline Industries, Inc.2004-03-25
MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 (K040203)Branan Medical Corp.2004-03-25
PRECISION VPS IMPRESSION MATERIAL (K040053)Discus Dental, Inc.2004-03-25
MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 (K040244)The Microoptical Corporation2004-03-24
ACCESS DHEA-S REAGENT ASSAY (K040181)Beckman Coulter, Inc.2004-03-24
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) (K040245)Roche Diagnostics Corp.2004-03-24
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH (K040521)American Medical Systems, Inc.2004-03-24
EASY LOOP, MODEL EZL-01 (K040110)Tools For Surgery, LLC2004-03-24
3I PATIENT-SPECIFIC OVERDENTURE BAR (K034035)Implant Innovations, Inc.2004-03-24
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 (K040050)Ge Medical Systems Navigation and Visualization IN2004-03-24
SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS (K040398)Power Medical Interventions, Inc.2004-03-24
IFL PROFESSIONAL SYSTEM, MODEL C100 (K040156)Cyden Limited2004-03-24
MEGVISION, MODEL EQ1000C SERIES (K040051)Eagle Technology, Inc.2004-03-24
MICRO TARGETING ELECTRODE (K033173)FHC, Inc.2004-03-24
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) (K032657)Home Diagnostics, Inc.2004-03-24
ENDOBOY (K033644)Geyser S.A.2004-03-24
CARDIOMD-AC (K040616)Danish Diagnostic Development A/S2004-03-24
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 (K040306)Biomedical Life Systems, Inc.2004-03-23
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D (K040691)Win-Us Technology Co., Ltd.2004-03-23
SYDNEY IVF PVP (K031304)Cook Urological, Inc.2004-03-23
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 (K024213)Siemens Medical Solutions USA, Inc.2004-03-23
TERUMO SURGUARD2 SAFETY NEEDLE (K040531)Terumo Medical Corp.2004-03-23
GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM (K040448)Rosner-Mautby Meditrade(Thailand) , Ltd.2004-03-23
BONE-LOK HP WASHER (K040250)Triage Medical, Inc.2004-03-23
ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS (K033109)Scient'X2004-03-23
ROBERTSITE VIAL ADAPTER, MODEL 245700021 (K040634)Halkey-Roberts Corp.2004-03-23
TRIGEN TROCHANTERIC ANTEGRADE NAIL (K040462)Smith & Nephew, Inc.2004-03-23
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (K033149)Ultimate Concepts, Inc.2004-03-23
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR (K040064)Newmedical Technology, Inc.2004-03-23
SUSTAIN RADIOLUCENT SPACER (K040284)Globus Medical, Inc.2004-03-23
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE (K040258)Synthes (Usa)2004-03-23
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) (K040532)Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd.2004-03-23
ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 (K034045)Oral Osteodistraction, L.P.2004-03-23
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F (K034050)Cordis Corporation2004-03-22
ZYOPTIX XP MICROKERATOME (K040204)Bausch & Lomb, Inc.2004-03-22
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM (K033977)Zeus Scientific, Inc.2004-03-22
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX (K032292)Bioteque Corp.2004-03-22
SOMATOM PROJECT P30L (K040577)Siemens Medical Systems, Inc.2004-03-22
NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM (K033000)Essex Cryogenics of Missouri, Inc.2004-03-22
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN (K033454)Brahms Diagnostica, LLC2004-03-22
INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS (K040205)Intra-Lock International2004-03-22
MODEL AVANT 2120 PULSE OXIMETER AND NIBP (K031487)Nonin Medical, Inc.2004-03-22
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER (K040541)Varian Medical Systems, Inc.2004-03-22
MESACUP TEST MPO, MODEL 11053 (K040586)Rhigene, Inc.2004-03-22
INFINITY MODULAR MONITORS VF4 MODIFICATIONS (K033694)Draeger Medical Systems, Inc.2004-03-22
APM BLOOD PRESSURE MONITOR, MODEL BP108A (K040159)Asia Pacific Microsystems, Inc.2004-03-22
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 (K040002)Microlife Intellectual Property Gmb2004-03-22
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL (K040640)Igc-Medical Advances, Inc.2004-03-22
MODIFICATION TO VERTE-STACK (K040422)Medtronic Sofamor Danek2004-03-19
SOLAR GI SYSTEM (K031084)Medical Measurement Systems B.V.2004-03-19
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 (K040359)Instrumentation Laboratory CO2004-03-19
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES (K033594)Contamac, Ltd.2004-03-19
KRYO ART CONTROLLED RATE FREEZER (K032086)Planer Plc2004-03-19
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 (K040229)A&D Engineering, Inc.2004-03-19
POWERPICC CATHETERS, MODELS 3175155, 3175135 (K033389)C.R. Bard, Inc.2004-03-19
CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 (K032864)Biolitec, Inc.2004-03-19
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS (K034024)Bisco, Inc.2004-03-19
ACCULASER PRO4 (K023060)Acculaser, Inc.2004-03-19
KERATO ANALYZER (EKA) (K040373)Konan Medical, Inc.2004-03-19
SHAPE LOCKING ENDOSCOPIC OVERTUBE (K033954)Usgi Medical, Inc.2004-03-19
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE (K040548)Harry J. Bosworth Co.2004-03-19
PEDIATRIC AORTIC ROOT CANNULA (K040173)Medtronic Perfusion Systems2004-03-19
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K040099)Becton, Dickinson & CO2004-03-19
CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 (K032863)Biolitec, Inc.2004-03-19
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V (K033998)Masimo Corp.2004-03-19
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE (K040547)Harry J. Bosworth Co.2004-03-19
ZAP HCG TEST, MODEL 8001 (K033297)Zbx Corporation2004-03-18
IVY DEVICES INC. IV/MEDICAL LINE STABILIZER (K033208)Ivy Devices, Inc.2004-03-18
ARIOL (K033200)Applied Imaging Corp.2004-03-18
VITALAB DIRECT BILIRUBIN REAGENT (K040631)Clinical Data, Inc.2004-03-18
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) (K040073)Sysmex America, Inc.2004-03-18
DUCERAGOLD PORCELAINS (K040421)Dentsply Intl.2004-03-18
INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905 (K040036)Inviro Medical2004-03-18
ALICE 5 (K040595)Respironics, Inc.2004-03-18
DUCERAM PLUS CERAMIC SYSTEM (K040420)Dentsply Intl.2004-03-18
MARK 5 NUVO (M5C5) (K032509)Nidek Medical Products, Inc.2004-03-18
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) (K032860)Immco Diagnostics, Inc.2004-03-18
ELLIPTIC MATRIX (K040539)Institut Straumann AG2004-03-18
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 (K040481)Intra Luminal Therapeutics, Inc.2004-03-18
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) (K032850)Immco Diagnostics, Inc.2004-03-18
IDI-MRSA (K033415)Infectio Diagnostic (I.D.I.), Inc.2004-03-18
DERMAWAVE 5000 COMBI MAX SYSTEM (K040121)Dermawave, LLC2004-03-17
RTIST (K033955)Mirada Solutions , Ltd.2004-03-17
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION (K040119)Synovis Surgical Innovations2004-03-17
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) (K040408)Shun Thai Rubber Gloves Industry Public Co., Ltd.2004-03-17
BIRD TBIRD VELA VENTILATOR (K032451)Bird Products Corp.2004-03-17
NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM (K040039)Barco N.V.2004-03-17
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 (K040538)American Medical Systems, Inc.2004-03-17
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING (K040558)Collagen Matrix, Inc.2004-03-17
TH0R DDII IR LAMP SYSTEM (K033923)Thor Intl.2004-03-17
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD (K040510)Vascular Solutions, Inc.2004-03-17
ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02 (K032896)Anson Medical , Ltd.2004-03-17
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