Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) (K063197)Totoku Electric Co., Ltd.2006-11-30
LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 (K063195)Valleylab2006-11-29
NOVATION SPLINED RDD FEMORAL STEMS (K063279)Exactech, Inc.2006-11-29
ARTHREX INTERFERENCE SCREW (K062466)Arthrex, Inc.2006-11-29
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE (K062592)Smiths Medical MD, Inc.2006-11-29
SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM (K062749)Nobel Biocare AB2006-11-29
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER (K063141)Omniguide, Inc.2006-11-29
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (K062581)Olympus America, Inc.2006-11-29
ULTICARE DISPOSABLE SYRINGES AND NEEDLES (K062702)Ultimed, Inc.2006-11-29
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP (K063060)Blueshine Srl2006-11-29
STIMULATING BUR GUARD (K063305)Medtronic Xomed, Inc.2006-11-29
OMNIPICC P.I. (K062579)Rita Medical Systems, Inc.2006-11-28
CAAS QCA 3D (K063344)Pie Medical Imaging BV2006-11-28
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X (K063288)Cardinal Health 303,Inc.2006-11-28
REGEN BIOCEMENT (K063010)Steiner Laboratories2006-11-28
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL (K063435)W. L. Gore & Associates, Inc.2006-11-28
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N (K062812)Thunder Tiger Corp.2006-11-28
AURORA (K063003)Parkell, Inc.2006-11-28
OX-SOX, MODEL C, D, E, (K062300)Pattient Safety Innovations, Llp2006-11-27
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN (K063299)Dade Behring, Inc.2006-11-27
ACCU-CHEK LINKASSIST (K063146)Disetronic Medical Systems AG2006-11-27
MOUTHGUARD AND ALIGNER MATERIALS (K062828)Dentsply Intl., Inc.2006-11-27
KLS MARTIN QUICK DISC (K062857)KLS Martin L.P.2006-11-22
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER (K061608)Hitachi Medical Corp.2006-11-22
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS (K063303)Zimmer, Inc.2006-11-22
PROFILER 2 (K063021)Sun Nuclear Corp.2006-11-22
HEARTSTART MRX MONITOR/DEFIBRILLATOR (K062233)Philips Medical Systems North America, Inc.2006-11-22
XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND (K063247)Imaging Dynamics Company , Ltd.2006-11-22
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR (K063273)Depuy Miltek, A Johnson & Johnson Co.2006-11-22
RETENTION FLOW OPAQUE (K062515)Heraeus Kulzer,GmbH2006-11-22
CALCIUM (K062855)Abbott Laboratories2006-11-22
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM (K062347)Bayer Healthcare, LLC2006-11-22
PTW DAVID IMRT QC VERIFICATION SYSTEM (K062817)Ptw-New York Corp.2006-11-22
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 (K062467)Axis-Shield Diagnostics, Ltd.2006-11-22
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND (K063246)Imaging Dynamics Company , Ltd.2006-11-22
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES (K061517)Prime Herbs Corporation2006-11-22
IVUS ENHANCER (K062985)Indec Systems, Inc.2006-11-22
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD (K062684)Aesculap, Inc.2006-11-22
RADIUS SPINAL SYSTEM (K062270)Stryker Spine2006-11-22
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS (K062638)Procter & Gamble Co.2006-11-22
FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT (K063257)Encore Medical L.P.2006-11-22
ORTHOVIEW (K063327)Merdian Technique, Ltd.2006-11-22
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 (K061951)Possis Medical, Inc.2006-11-22
PROPATCH SOFT TISSUE REPAIR MATRIX (K061892)Cryolife, Inc.2006-11-22
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET (K062593)Compass Bioscience2006-11-22
MODIFICATION TO EXPEDIUM SPINE SYSTEM (K063156)Depuy Spine, Inc.2006-11-22
ECLIPSE TOTAL ANKLE IMPLANT (K061749)Kinetikos Medical, Inc.2006-11-22
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (K061948)CooperVision, Inc.2006-11-22
DX-SI (K063421)Agfa Corp.2006-11-22
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST (K061617)Tianjin New Bay Bioresearch Co., Ltd.2006-11-22
BIOHORIZONS CERAMIC ABUTMENT (K061567)BioHorizons Implant Systems, Inc.2006-11-22
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V (K062637)Ortho-Clinical Diagnostics, Inc.2006-11-22
ACTIVASCREW (K062980)Bioretec, Ltd.2006-11-22
MICRO-INFUSION SYSTEM (K062507)Ekos Corp.2006-11-22
ADJUST-RIGHT FIXATION DEVICES (K062734)Valpo Orthopedic Technology, Inc.2006-11-22
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM (K063212)Taidoc Technology Corporation2006-11-22
MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM (K063138)Siemens Medical Solutions USA, Inc.2006-11-22
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V (K062094)Ortho-Clinical Diagnostics, Inc.2006-11-22
VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062077)Ortho-Clinical Diagnostics, Inc.2006-11-22
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY (K063330)Orthocon, Inc.2006-11-22
GREENTON ECOLITE IPL SYSTEM (K062721)Greenton (London) , Ltd.2006-11-21
BIOAGGREGATE (K063422)Innovative Bioceramix, Inc.2006-11-21
TELEMEDICINE SYSTEM MODEL VMS-01 (K062662)Medic4all (Israel) , Ltd.2006-11-21
STIMUPLEX PEN (K061983)Stockert GmbH2006-11-21
EXCELART VANTAGE ATLAS, MODEL MRT-1503 (K063361)Toshiba America Medical Systems, In.C2006-11-21
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 (K063291)Choice Smart Health Care Co. , Ltd.2006-11-21
ENAMEL PRO VARNISH (K062683)Premier Dental Products Co.2006-11-21
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 (K063178)C.R. Bard, Inc.2006-11-21
SMITH & NEPHEW RF CANNULAE (K063467)Smith & Nephew, Inc.2006-11-21
ONCOBIONIC SYSTEM (K060054)Oncobionics, Inc.2006-11-21
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL (K063161)Leonhard Lang GmbH2006-11-21
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR (K063240)C.R. Bard, Inc.2006-11-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML (K062945)Becton, Dickinson & CO2006-11-21
FIDIS TM THYRO, MODEL MX002 (K061794)Biomedical Diagnostics (Bmd) SA2006-11-21
MODIFICATION TO BIOMARC TISSUE MARKER (K063193)Carbon Medical Technologies, Inc.2006-11-21
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (K062183)The Binding Site, Ltd.2006-11-21
ON-Q INTRODUCERS (K063234)I-Flow Corp.2006-11-21
M3 (K063333)Mavig GmbH2006-11-21
FLEXPEN NEEDLE (K062500)Novo Nordisk, Inc.2006-11-21
CADWELL EASYNET NASAL PRESSURE MODULE (K061705)Cadwell Laboratories, Inc.2006-11-21
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU (K050263)M.O. Com S.R.L.2006-11-21
PORTABLE OXYGEN GENERATOR SYSTEM (K062153)Molecular Products , Ltd.2006-11-21
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S (K062212)Anacapa Technologies, Inc.2006-11-21
THE 5.0 X 6.0MM DENTAL IMPLANT (K062044)Bicon, Inc.2006-11-21
LONGPORT EPISCAN, MODEL-I-200 (K062571)Longport, Inc.2006-11-21
AESCULAP PNEUMATIC KERRISON (K062413)Aesculap, Inc.2006-11-21
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY (K062781)Symtium Corporation2006-11-21
ENAMEL PRO (K062166)Premier Dental Products Co.2006-11-21
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 (K062822)Vascular Solutions, Inc.2006-11-21
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 (K062746)Medicon Hellas S.A2006-11-20
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML (K062938)Dade Behring, Inc.2006-11-20
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 (K063315)Philips Medizin Systeme Boeblingen GmbH2006-11-20
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K061101)Diagnostic Hybrids, Inc.2006-11-20
CADI, VERSION 4 (K062237)Synca Marketing, Inc.2006-11-20
LAVA SOFTWARE (K062493)3M Espe AG Dental Products2006-11-17
APERFIX FEMORAL IMPLANT WITH INSERTER (K062487)Cayenne Medical, Inc.2006-11-17
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE (K062399)Rockwell Medical Technologies, Inc.2006-11-17
INJEKT SYRINGE (K063280)B.Braun Medical, Inc.2006-11-17
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES (K061829)New Leaf Medical, Inc.2006-11-17
ASAHI PRECIOUS GUIDE CATHETER (K061601)Asahi Intecc Co., Ltd.2006-11-17
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Every clearance here is in the API, with alerts when new ones post.