Atlas FDA

2008

3,053 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODULAR FOOT SYSTEM (K073624)Orthohelix Surgical Designs, Inc.2008-03-20
COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX (K071694)Daiken Medical Co, Ltd.2008-03-20
SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM (K072116)Neurospine Innovations and Solutions2008-03-20
RESPIRONICS GOLOX (K072723)Respironics, Inc.2008-03-20
ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE (K073652)Nakamura Magnifier Co., Ltd.2008-03-20
CLARIVEIN CATHETER (K071468)Vascular Insights, LLC2008-03-20
ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 (K080482)Arthrocare Corp.2008-03-20
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE (K073653)Trek Diagnostic Systems, Inc.2008-03-20
SLEEP QUALITY (K070855)Dynadx Corporation2008-03-20
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS (K080204)Biomet, Inc.2008-03-20
ACUITY UNIVERSAL CUTTER (K080154)Cardiac Pacemakers, Inc.2008-03-20
SWIFT LT (K073638)Resmed, Ltd.2008-03-20
PSS SYSTEM (K073240)Spinal USA2008-03-20
RUNTHROUGH NS EXTENSION WIRE (K080563)Terumo Medical Corp.2008-03-20
PIONEER LOWTOP SPINAL ROD SYSTEM (K080504)Pioneer Surgical Technology2008-03-20
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 (K073363)Paladin Biomedical Corporation2008-03-20
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS (K073637)Biomet Manufacturing Corp2008-03-20
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 (K073227)Aiia Communication, Inc.2008-03-20
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (K080109)Synthes (Usa)2008-03-20
COLOR LCD MONITOR, MODEL RADIFORCE RX211 (K080457)Eizo Nanao Corporation2008-03-20
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM (K080518)Pioneer Surgical Technology2008-03-20
SECURE (K073698)Parkell, Inc.2008-03-19
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER (K080291)Intuitive Surgical, Inc.2008-03-19
SINUS SPACER (K072891)Acclarent, Inc.2008-03-19
KANTERON DICOM STATION (KDS), MODEL 3.0 (K073176)Monica Veytia2008-03-19
LED.L, LED.M, LED.G, LED.B (K080025)Guilin Woodpecker Medical Instrument Co., Ltd.2008-03-19
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 (K072036)Biokit, S.A.2008-03-19
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 (K073095)Somatex Medical Technologies GmbH2008-03-19
VARIAX DISTAL RADIUS TORX SCREWS (K080667)Howmedica Osteonics Corp.2008-03-19
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K072527)Zoll Circulation2008-03-19
TRAUMACAD VERSION 2.0 (K073714)Orthocrat, Ltd.2008-03-19
STRYKER ANTIMIC CATHETER (K072702)Stryker Instruments, Instruments Div.2008-03-19
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 (K080166)Beckman Coulter, Inc.2008-03-19
DURETTE IMPLANT (K073293)Oculo Plastik, Inc.2008-03-19
SBI SR MTP TOE IMPLANT (K073635)Small Bone Innovations, Inc.2008-03-19
MEDLINE GASTROSTOMY TUBE (K073718)Medline Industries, Inc.2008-03-19
ACTIVATED ASPARTATE AMINOTRANSFERASE (K071525)Abbott Laboratories2008-03-19
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 (K072301)Ev3, Inc.2008-03-18
MUSCLE PAIN DEVICE (MPD) (K073361)Stevens Proof of Concept, Inc.2008-03-18
DRIVE SOLSTICE OXYGEN CONCENTRATOR (K080391)Medical Depot2008-03-18
HENKE SASS WOLF OF AMERICA ARTHROSCOPE (K080560)Henke Sass Wolf of America, Inc.2008-03-18
EVIS EXERA II 180 SYSTEM (K072957)Olympus Medical Systems Corporation2008-03-18
SPINAL SPHERE SYSTEM (K073274)Life Spine2008-03-17
SUTTER ELECTROSURGICAL CABLES (K073450)Sutter Medizintechnik GmbH2008-03-17
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS (K072686)Axis-Shield Diagnostics, Ltd.2008-03-17
RX DC X-RAY UNIT (K080076)Cefla S.C.R.L.2008-03-14
NOCC HYDROPHILIC WOUND DRESSING (K080010)Kytogenics, Inc.2008-03-14
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM (K073265)Apieron, Inc.2008-03-14
SUB-TALAR LOK, MODEL 7-11 MM (K080280)Instratek, Inc.2008-03-14
OCCLUFAST CAD (K080130)Zhermack S.P.A.2008-03-14
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM (K080211)Toshiba America Medical Systems, In.C2008-03-14
QUANTITATIVE NEUROQ 3.0 (K072307)Syntermed, Inc.2008-03-14
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) (K073034)Applied Medical Technology, Inc.2008-03-14
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (K073401)Micromedics, Inc.2008-03-14
IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) (K063175)Medical Technology Systems, Inc.2008-03-14
SENSITITRE 18-24 SUSCEPTIBILITY PLATE (K073558)Trek Diagnostic Systems, Inc.2008-03-13
PREVADH MESH (K073287)Sofradim Production2008-03-13
MODIFICATION TO REBOUND HRD (K080393)Minnesota Medical Development, Inc.2008-03-13
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (K073591)Staar Surgical Co.2008-03-13
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 (K071120)Aemed, Inc.2008-03-13
TINNITUS SOUND GENERATOR MODULE (K073636)Gn Resound A/S2008-03-13
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM (K080394)Blackstone Medical, Inc.2008-03-13
ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX (K073343)Ace Surgical Supply Co., Inc.2008-03-13
INPLEX CF MOLECULAR TEST (K063787)Third Wave Technologies, Inc.2008-03-13
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (K072864)St. Jude Medical, Cardiac Rhythm Management Divisi2008-03-13
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R (K073324)Medtronic, Inc.2008-03-13
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 (K080461)Philips Medical Systems2008-03-13
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 (K080540)Neusoft Medical Systems Co., Ltd.2008-03-13
MOUNTABLE ENDOSCOPIC BLADE (K080133)A.M. Surgical, Inc.2008-03-13
ATLANTIS 018 PERIPHERAL IMAGING CATHETER (K073623)Boston Scientific Corp2008-03-13
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD (K073604)Dade Behring, Inc.2008-03-13
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 (K080500)Acumen Medical, Inc.2008-03-13
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 (K073260)Device Partners International2008-03-13
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (K073586)Staar Surgical Co.2008-03-13
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES (K073567)Zimmer GmbH2008-03-13
BLACKSTONE SFS PARALLEL ROD CONNECTORS (K080407)Blackstone Medical, Inc.2008-03-13
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL (K072256)Hill Laboratories Co.2008-03-12
POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR (K072197)Metacure Surgical Gloves Sdn Bhd2008-03-12
STERILS SINGLE-USE I/A HANDPIECES (K073023)Bausch & Lomb, Inc.2008-03-12
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE (K080352)Depuy Mitek, A Johnson & Johnson Company2008-03-12
DANYANG HUAYI K2 AND K7 WHEELCHAIRS (K080207)Danyang Huayi Medical Supply & Equipment Co, Ltd.2008-03-12
SLENDERTONE ENERVIVE, MODEL 561 (K071666)Bio-Medical Research Corp.2008-03-12
DUAL CHAMBER TPN CONTAINER (K073538)B.Braun Medical, Inc.2008-03-12
AMICAS VISION SERIES PACS, MODEL 5.5 (K073526)Amicas, Inc.2008-03-12
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR (K080087)Edan Instruments, Inc.2008-03-11
KFH ENERGY, MODEL: E1 (K073008)Kingfisher Healthcare NV2008-03-11
DRAEGER ALCOTEST 6510 (K063443)Drager Safety2008-03-11
GRAFTYS BCP (K073064)Graftys2008-03-11
ATRICURE COOLRAIL LINEAR PEN (K073605)AtriCure, Inc.2008-03-11
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (K073041)Acclarent, Inc.2008-03-11
MODIFICATION TO VIEWMATE SYSTEM (K073709)Ep Medsystems2008-03-11
ATLANTIS PVIMAGING CATHETER, MODEL H749364560 (K080272)Boston Scientific Corp2008-03-11
TRANS1 FACET SCREW (K073515)Trans1 Incorporated2008-03-11
INTEGRE, MODEL LP581 (K080423)Ellex Medical Pty, Ltd.2008-03-11
KIMBA MINI (K080349)Signus Medizintechnik GmbH2008-03-10
OMNI-VUE SYSTEM (K073062)Genesis Digital Imaging, Inc.2008-03-10
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 (K073484)Ethicon Endo-Surgery, Inc.2008-03-10
IPULSE, MODEL I400 (K080406)Cyden Limited2008-03-10
HFO SHOULDER COIL (K080120)Philips Medical Systems MR Finland2008-03-10
SYSTEM PLUS (K073475)Continental Dental Laboratory2008-03-10
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Every clearance here is in the API, with alerts when new ones post.