Atlas FDA

2005

3,156 FDA 510(k) clearances · Clearance year

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RecordFirmDate
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (K051446)First Quality Hygienic, Inc.2005-07-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML (K051692)Becton, Dickinson & CO2005-07-14
19-INCH (48CM) COLOR LCD MONITOR CDL1904A (K051403)Totoku Electric Co., Ltd.2005-07-14
BARRIER SURGICAL DRAPES (K051625)Molnlycke Health Care, Inc.2005-07-14
ECHOSYSTEM (K051745)Medstrat, Inc.2005-07-14
READMYHEART, MODEL RMH3.0 (K050620)Dailycare Biomedical, Inc.2005-07-14
TORNIER ELBOW PROSTHESIS (K050848)Tornier2005-07-14
ILAB ULTRASOUND IMAGING SYSTEM (K051679)Boston Scientific Corp2005-07-14
POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 (K051547)Tpc Advanced Technology, Inc.2005-07-14
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) (K050410)Hwang Sun Enterprise Co., Ltd.2005-07-14
CARDIOMEM CM 3000-12 (K051686)Getemed Medizin- Und Informationstechnik AG2005-07-14
NOMAD DENTAL X-RAY SYSTEM (K051795)Aribex, Inc.2005-07-14
CONMED IRRIGATION NOZZLE (K050992)Conmedcorp2005-07-14
CERETOM, MODEL NL3000 (K051765)Neurologica Corporation2005-07-14
ANGIODYNAMICS TUMESCENT INFUSION DEVICE (K051142)AngioDynamics, Inc.2005-07-13
TISSU-TRANS (K050797)Shippert Medical Technologies Corp.2005-07-13
SEMIAL SPINAL IMPLANT (K051659)Signus Medizintechnik GmbH2005-07-13
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR (K051049)Synthes (Usa)2005-07-13
CS MEDICAL TTCF GAS DELIVERY SYSTEM (K050381)Cs Medical, Inc.2005-07-13
3TEST GLUCOSE MONITORING SYSTEM (K050224)Neuero Engineering, Inc.2005-07-13
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY (K051359)Candela Corp.2005-07-13
T-PLATE ANTERIOR FIXATION SYSTEM (K051764)Esm Technologies2005-07-13
K-C HEMOSTATIC BIOPSY SYSTEM (K050135)Bioengineering Consultants , Ltd.2005-07-13
TRIATHLON KNEE SYSTEM (K051146)Howmedica Osteonics Corp.2005-07-13
PROTEGE ULTRASONIC INSERT (K051776)Discus Dental, Inc.2005-07-13
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (K051549)Digirad Corp.2005-07-13
IMPEDIMED - BODY COMPOSITION ANALYSIS (K050395)Impedimed Pty , Ltd.2005-07-13
CS MEDICAL ADULT TTCF CATHETER (K050379)Cs Medical, Inc.2005-07-12
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN (K051311)Dade Behring, Inc.2005-07-12
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL (K051339)R&D Systems, Inc.2005-07-12
SIDEKICK BLOOD GLUCOSE TEST SYSTEM (K051147)Home Diagnostics, Inc.2005-07-12
HUBER CLEAR SAFETY INFUSION SET (K051009)Now Medical Distribution, Inc.2005-07-12
BIOLOX DELTA CERAMIC FEMORAL HEADS (K051588)Howmedica Osteonics Corp.2005-07-12
XENO ADHESIVE WITH ACTIVATOR (K051463)Dentsply Intl.2005-07-12
RAPID READER (K041696)American Bio Medica Corp.2005-07-12
EVITAXL WITH OPTION SMARTCARE (K051263)Drager Medical AG & Co. Kgaa2005-07-12
MODIFICATION TO LNCS OXIMETRY SENSORS (K051212)Masimo Corporation2005-07-12
SOMNOMED MAS RXA (K050592)Somnomed, Ltd.2005-07-12
MALIBU SPINAL SYSTEM (K051663)Seaspine, Inc.2005-07-12
INSPIRATION VENTILATOR SYSTEM (K051550)eVent Medical, Ltd.2005-07-12
RELIADENT DENTAL IMPLANT SYSTEM (K043428)Bioinfera, Inc.2005-07-12
POWDERED LATEX PATIENT EXAMINATION GLOVES (K051465)P.T. Anlis Abadi Internasional2005-07-12
ZILVER 635 BILIARY STENT (K051124)Cook, Inc.2005-07-12
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES (K050968)Pt. Medisafe Technologies2005-07-12
ENDOSSEOUS DENTAL IMPLANT ABUTMENT (K051011)Atlantis Components, Inc.2005-07-12
HUMERAL HEAD PLATE WITH ANGULAR STABILITY (K051412)I.T.S. Implantat-Technologie-Systeme GmbH2005-07-11
REPROCESSED MULTIPLE CLIP APPLIERS (K033579)Clearmedical, Inc.2005-07-11
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (K050960)Wallac OY2005-07-11
DIMENSION VISTA INTEGRATED SYSTEM (K051087)Dade Behring, Inc.2005-07-11
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (K051621)Alveolus, Inc.2005-07-11
GONGDONG DISPOSABLE VAGINAL SPECULUM (K050887)Zhejiang Gongdong Medical Plastic Factory2005-07-11
ROI FUSION RODS & PLATES (K051309)Reiley Orthopaedics, Inc.2005-07-11
SOLCO 4CIS GENERAL PLATE SYSTEM (K051155)Solco Biomedical Co., Ltd.2005-07-11
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) (K051752)Roche Diagnostics2005-07-11
SEPRAGEL ENT BIORESORBABLE PACKING/STENT (K043035)Genzyme Corporation2005-07-11
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM (K051384)Nuvasive, Inc.2005-07-11
HEMORAM/AGGRAM ANALYZER (K050053)Helena Laboratories2005-07-11
REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (K033578)Clearmedical, Inc.2005-07-11
THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM (K050342)Theralase, Inc.2005-07-11
ZUTRON COLONOSCOPE STIFFENING DEVICE (K051068)Zutron Medical2005-07-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML (K051272)Becton, Dickinson & CO2005-07-11
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT (K051668)Goodmark USA, Inc.2005-07-08
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. (K051530)American Medical Systems, Inc.2005-07-08
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (K051108)Abaxis, Inc.2005-07-08
IMASK, MODELS 100, 200 AND 300 (K051559)Vital Signs Colorado, Inc.2005-07-08
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 (K051262)Respironics California, Inc.2005-07-08
UNITY NETWORK ID (K051518)Ge Medical Systems Information Technologies2005-07-08
SINGLE USE BALLOON DILATOR MAXPASSTM (K050502)Olympus Winter & Ibe GmbH2005-07-08
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT (K050832)Bard Peripheral Vascular, Inc.2005-07-07
SMARTECH, MODEL HOLI I (K050507)Cycling and Health Tech. Industry R&D Center2005-07-07
PIVOT BIPOLAR FEMORAL HEAD (K050966)Ortho Development Corp.2005-07-07
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 (K051524)Smiths Medical Asd, Inc.2005-07-07
GE OEC EVERVIEW 7500 (K051490)Ge Oec Medical Systems, Inc.2005-07-07
RN SYNOCTA TEMPORARY MESO ABUTMENT (K051717)Institut Straumann SA2005-07-07
CONNEXUS (K050690)Isotis Orthobiologics, Inc.2005-07-07
BD DIRECTIGEN EZ FLU A + B (K042472)Becton, Dickinson & CO2005-07-07
LANDLEX MODEL S400X (K050793)Cycling and Health Tech. Industry R&D Center2005-07-07
FUJI SYNAPSE WORKSTATION SOFTWARE (K051553)Fujifilm Medical Systems U.S.A, Inc.2005-07-07
PALACOS LV+G (K050854)Heraeus Kulzer,GmbH2005-07-07
MERETE TWISTCUT SNAP-OFF BONE SCREW (K051323)Merete Medical GmbH2005-07-07
NATURE-CRYL HI PLUS (K051358)GC America, Inc.2005-07-07
QUANTUM VERTEBRAL BODY REPLACEMENT (K050449)Quantum Orthopedics, Inc.2005-07-07
NOBELREPLACE ADAPTER, MODEL 32412 (K050444)Nobel Biocare Uas, Inc.2005-07-07
POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) (K051372)Platinum Glove Industries Sdn. Bhd.2005-07-07
T2 RECON NAIL SYSTEM (K051624)Howmedica Osteonics Corp.2005-07-07
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES (K051098)Zimmer, Inc.2005-07-07
PALAMED G (K050855)Heraeus Kulzer,GmbH2005-07-07
AXIOM SIRESKOP SD (K051602)Siemens Medical Systems, Inc.2005-07-07
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET (K050231)Roche Diagnostics Corp.2005-07-06
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES (K043238)Emg Technology Co., Ltd.2005-07-06
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR (K051498)Ever Global Enterprise Corporation2005-07-06
ELECSYS CA 19-9 CALCHECK (K051185)Roche Diagnostics Corp.2005-07-06
1,25-DIHYDROXY VITAMIN D EIA (K051110)Immunodiagnostic Systems , Ltd.2005-07-06
RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT (K051268)Radiancy, Ltd.2005-07-06
JAUNDICE METER, MODEL JM 103 (K042522)Draeger Medical Infant Care, Inc.2005-07-06
NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486)Norwood Abbey , Ltd.2005-07-06
QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) (K042725)Quest Diagnostics, Inc.2005-07-06
EXPEDIUM SPINE SYSTEM (K051024)Depuy Spine, Inc.2005-07-06
ELECSYS PRECICONTROL ANEMIA (K051517)Roche Diagnostics Corp.2005-07-05
FRAXEL SR LASER SYSTEM (K050841)Reliant Technologies, Inc.2005-07-05
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Every clearance here is in the API, with alerts when new ones post.