Atlas FDA

2006

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

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RecordFirmDate
TRU-MR LARYNGOSCOPE SET (K062523)Truphatek International, Ltd.2006-11-17
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54 (K063389)Pride Mobility Products Corp.2006-11-17
FLEX LOOP COIL SET 3T (K063373)Siemens AG2006-11-17
NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB (K062131)Barcoview2006-11-17
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED (K062851)Osteomed LP2006-11-17
RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 (K061375)Louis M. Gerson Co., Inc.2006-11-17
DEFINIUM 5000 X-RAY SYSTEM (K063283)Sedecal., Sa.2006-11-17
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) (K063046)Hartalega Sdn Bhd2006-11-17
RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES (K063185)Radiant Innovation, Inc.2006-11-17
AESCULAP STERILCONTAINER SYSTEM (K062510)Aesculap2006-11-17
RETINAL FUNCTIONAL IMAGER (RFI) (K062416)Optical Imaging , Ltd.2006-11-17
ENA HFO COMPOSITE SYSTEM (K062906)Micerium S.P.A.2006-11-17
SIERRA (K062934)Seaspine, Inc.2006-11-16
C-PORT DISTAL ANASTOMOSIS SYSTEM (K053524)Cardica, Inc.2006-11-16
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT (K052716)Otsuka Pharmaceutical Co., Ltd.2006-11-16
IMPRESSIX, COLORCHANGE ALGINATE (K062400)Cavex Holland BV2006-11-16
KINETIC ANTERIOR CERVICAL PLATE (K062643)Life Spine2006-11-16
HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER (K061933)Hager Worldwide, Inc.2006-11-16
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062123)Ortho-Clinical Diagnostics, Inc.2006-11-16
2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC (K063289)Chi Lin Technology Co., Ltd.2006-11-16
ELI 350 ELECTROCARDIOGRAPH (K062677)Mortara Instrument, Inc.2006-11-15
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML (K062944)Becton, Dickinson & CO2006-11-15
RIVA LUTING PLUS (K062065)Southern Dental Industries, Inc.2006-11-15
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM (K061002)U&I Corp.2006-11-15
TENACORE SP02 SENSORS (K053420)Tenacore Holdings, Inc.2006-11-15
TRIDENT LARGE DIAMETER ACETABULAR INSERTS (K062419)Howmedica Osteonics Corp.2006-11-15
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES (K063302)Shanghai Dental Instrument Factory2006-11-15
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS (K062262)Ciba Vision Corporation2006-11-14
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM (K063085)Siemens Medical Solutions USA, Inc.2006-11-14
ATB ADVANCED PTA DILATATION CATHETER (K063252)Cook, Inc.2006-11-14
DENLASER 800 PLUS (K062619)CAO Group, Inc.2006-11-14
IRIDEX WIRELESS FOOTSWITCH (K062074)Iridex Corp2006-11-14
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE (K062871)Lynton Lasers Limited2006-11-14
SPIDERFX EMBOLIC PROTECTION DEVICE (K063204)Ev3, Inc.2006-11-14
IMAX CEPH DIGITAL X-RAY SENSOR (K062403)Owandy2006-11-14
BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 (K062441)Barrx Medical, Incorporated2006-11-14
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 (K063222)Cardionet, Inc.2006-11-14
SYNTHES ANTEGRA SYSTEM (K063158)Synthes Spine Co.Lp2006-11-14
INNOVACON SPECTRUM II TEST CARD (K061718)Innovacon, Inc.2006-11-13
IQQA-LIVER SOFTWARE (K061696)Edda Technology, Inc.2006-11-13
MEDLINE HYPODERMIC NEEDLES (K062984)Medline Industries, Inc.2006-11-13
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (K062920)Orthofix Srl2006-11-13
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144)Ortho-Clinical Diagnostics, Inc.2006-11-13
ORTHROPRO HEMI TOE (K062908)Orthopro, LLC2006-11-13
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 (K062434)Agamatrix2006-11-13
SALTO TALARIS TOTAL ANKLE PROSTHESIS (K060544)Tornier2006-11-13
SBI LATERAL RHEAD IMPLANT (K062898)Small Bone Innovations, Inc.2006-11-13
S-SCAN MRI SYSTEM (K063207)Esaote, S.p.A.2006-11-09
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC (K063266)Chi Lin Technology Co., Ltd.2006-11-09
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K062884)Suqian Green Glove Co., Ltd.2006-11-09
ISITE PACS, V 4. X (K063267)Stentor Inc., A Philips Medical Systems Co.2006-11-09
COLOR LCD MONITOR, RADIFORCE, MODEL RX210 (K063120)Eizo Nanao Corporation2006-11-09
SMITHWICK CAROTID SHUNT (K062474)Mcpherson Enterprises, Inc.2006-11-09
BINAXNOW INFLUENZA A & B TEST (K062109)Binax, Inc.2006-11-09
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062839)Trek Diagnostic Systems, Inc.2006-11-09
RIVA BOND LC (K062064)Southern Dental Industries, Inc.2006-11-09
TOMAS PIN SD 6, 8, AND 10 MM (K062733)Dentaurum2006-11-09
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION (K063241)Toshiba America Medical Systems, In.C2006-11-09
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) (K063102)Dade Behring, Inc.2006-11-09
AEQUALIS SHOULDER SYSTEM (K063081)Tornier2006-11-09
DIGITAL MXR-D FLOWMETER (K062155)Porter Instrument Co., Inc.2006-11-09
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K062955)Pt. Haloni Jane2006-11-09
SOYALA FULL FACE MASK (K061653)Weinmann Gerate Fur Medizin GmbH + Co. KG2006-11-09
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J (K062186)Asahi Intecc Co., Ltd.2006-11-09
GORE PROPATEN VASCULAR GRAFT (K062161)W. L. Gore & Associates, Inc.2006-11-09
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE (K062384)Isoray, Inc.2006-11-09
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR (K062241)North American Scientific, Inc.2006-11-09
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T (K062605)Philips Medical Systems2006-11-09
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 (K062782)Inion OY2006-11-09
KARL STORZ VIDEO GASTROSCOPES (K060907)KARL STORZ Endoscopy-America, Inc.2006-11-09
HALO90 COAGULATION CATHETER (K062723)Barrx Medical, Incorporated2006-11-09
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K062930)Alcon Research, Ltd.2006-11-08
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) (K062127)Medic4all (Israel) , Ltd.2006-11-08
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR (K061935)Sensacare , Ltd.2006-11-08
K-ETCHANT GEL (K062409)Kuraray Medical, Inc.2006-11-08
IRIDEX OCULIGHT TX (K062369)Iridex Corp2006-11-08
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 (K061905)Medcon , Ltd.2006-11-08
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 (K061848)Hypermed, Inc.2006-11-08
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION (K062228)Zimmer, Inc.2006-11-08
XERON PACS (K062757)Xeron Healthcare Corp.2006-11-07
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A (K052599)Suzhou 66 Vision Tech Co., Ltd.2006-11-07
HEPASPHERE MICROSPHERES (K052742)Biosphere Medical, Inc.2006-11-07
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 (K062043)Omron Healthcare, Inc.2006-11-07
HUMERAL HEAD, MANUAL DRIVER (K062422)Vidacare Corporation2006-11-07
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (K062440)Gen-Probe, Inc.2006-11-07
SECTRA WORKSTATION, VERSION 11.1 (K063093)Sectra Imtec AB2006-11-07
I-STOP TRANS OBTURATOR MALE SLING (K063079)Cl Medical2006-11-07
ART SHIELDED BREAST APPLICATOR (K062135)Advanced Radiation Therapy, LLC2006-11-07
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K063083)Medtronic Sofamor Danek, Inc.2006-11-06
TSRH SPINAL SYSTEM (K062807)Medtronic Sofamor Danek, Inc.2006-11-06
CELLU M6 KEYMODULE I (K053225)Lpg One, Inc.2006-11-06
CRYOMATIC (K062412)Keeler Instruments, Inc.2006-11-06
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 (K062886)CAO Group, Inc.2006-11-06
NICOLETONE SYSTEM V32 AMPLIFIER (K061908)Viasys Neuro Care2006-11-06
VOYAGER 12 (K062469)Del Mar Reynolds Medical, Ltd.2006-11-03
EQUIVITAL, MODEL EQ-01 (K061993)Hidalgo Limited2006-11-03
VENTED VIAL ADAPTER TRANSFER DEVICE (K062482)Medimop Medical Projects, Ltd.2006-11-03
SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW (K062715)Baoding Guanzhong Glove Co., Ltd.2006-11-03
TSX-301A, AQUILION ONE CT SYSTEM (K063189)Toshiba America Medical Systems, In.C2006-11-03
CONFIDENCE FENESTRATED INTRODUCER NEEDLE (K063067)Disc-O-Tech Medical Technologies, Ltd.2006-11-03
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Every clearance here is in the API, with alerts when new ones post.