Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY (K071499)Aesculap Implant Systems, Inc.2007-09-14
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES (K071651)Endogastric Solutions, Inc.2007-09-14
AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE (K071567)Autosafe-Refelx, Inc.2007-09-14
CAPLESS LI PEDICLE SCREW SYSTEM (K072282)X-Spine Systems, Inc.2007-09-14
BACTRACK LCD ALCOHOL DETECTOR (K071067)Khn Solutions, LLC2007-09-14
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K070742)Medtronic Sofamor Danek2007-09-14
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL (K071170)Smart Glove Corp. Sdn Bhd2007-09-14
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (K072445)Nucletron Corp.2007-09-14
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 (K072246)Maine Standards Co.2007-09-14
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM (K063481)Abbott Vascular, Inc.2007-09-14
OLYMPUS CAPSULE ENDOSCOPE SYSTEM (K063259)Olympus Medical Systems Corporation2007-09-14
SIASCOPE V (K062736)Astron Clinica Limited2007-09-14
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 (K070685)Tyco Healthcare2007-09-14
SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS (K072090)Siemens Medical Solutions USA, Inc., Ultrasound DI2007-09-14
GREINER VACUETTE QUICKSHIELD COMPLETE (K072320)Greiner Bio-One North America, Inc.2007-09-14
TRANS-CATHETER EXTRACTOR (K063048)Tran Pa-C, Inc.2007-09-14
TOTAL PROTEIN URINE/CSF GEN.3 (K071239)Roche Diagnostics2007-09-14
BRM3 BRAIN MONITOR (K071449)Brainz Instruments , Ltd.2007-09-14
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE (K072405)Usgi Medical2007-09-13
CURE CATHETER (K072539)Cure Medical, LLC2007-09-13
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES (K072387)KARL STORZ Endoscopy-America, Inc.2007-09-13
DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL (K072150)Novocol, Inc.2007-09-13
STATIS DENTAL HANDPIECES (K071891)Scican , Ltd.2007-09-13
STRYKER MODULAR HIP SYSTEM (K071082)Howmedica Osteonics Corp.2007-09-13
BRK TRANSSEPTAL NEEDLE (K072278)St Jude Medical2007-09-13
ARCHITECT STAT TROPONIN-1; MYOGLOBIN (K070640)Fisher Diagnostics2007-09-13
MRSASELECT (K070361)Bio-Rad2007-09-13
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER (K072418)Respironics New Jersey, Inc.2007-09-12
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C (K071437)KARL STORZ Endoscopy-America, Inc.2007-09-12
ELLIPSE JUVIA, MODEL 9EJU7465 (K072023)Ellipse A/S2007-09-12
SENTEC DIGITAL MONITORING SYSTEM (K071672)Sentec AG2007-09-12
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN (K072038)bioMerieux, Inc.2007-09-12
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM (K072297)Cardiva Medical, Inc.2007-09-12
TROJAN THINTENSITY BRAND MALE LATEX CONDOM (K071272)Church & Dwight Co., Inc.2007-09-12
PORTRAIT STAND-OFF (K072394)Rhytec Incorporated2007-09-12
CPAP NASAL MASK WITH PILLOWS (K071773)Lifesource2007-09-12
REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS (K070859)Sterilmed, Inc.2007-09-12
C350 POWERED WHEELCHAIR (K071650)Permobil AB2007-09-12
POCKETCPR (K071321)Bio-Detek, Inc.2007-09-12
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 (K070653)Tyco Healthcare2007-09-12
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED (K072308)Sorin Group Italia S.R.L.2007-09-12
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER (K063609)Shl Telemedicine International , Ltd.2007-09-12
NEOPIP INFANT RESUSCITATOR (K072021)Neoforce Group, Inc.2007-09-12
INTRAVASCULAR INTRODUCER SYSTEM (K063658)Applied Medical Resources Corp.2007-09-12
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (K071644)Roche Diagnostics Corp.2007-09-12
FIDUCIAL MARKERS (K071614)Civco2007-09-11
MODUS TRILOCK 2.0/2.3/2.5 (K071612)Medartis AG2007-09-11
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R (K070590)Microlife Intellectual Property GmbH2007-09-11
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT (K071465)Molnlycke Health Care Us, LLC2007-09-11
FLEXWARMER, MODELS KZ-1 AND KZ-2 (K062644)Merlyn Associates, Inc.2007-09-11
DELTA XTEND REVERSE SHOULDER MODULAR STEM (K071379)DePuy Orthopaedics, Inc.2007-09-11
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT (K071700)Molnlycke Health Care Us, LLC2007-09-11
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS (K072151)Straumann USA2007-09-11
TRIBONE 80 (K071121)Biomatlante2007-09-11
COR ANALYZER II, MODEL V1.7 (K072242)Rcadia Medical Imaging , Ltd.2007-09-11
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS (K070554)DePuy Orthopaedics, Inc.2007-09-11
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H (K071980)Dade Behring, Inc.2007-09-11
TI2200 TRANSILLUMINATION CABLE (K071429)Kerr Corporation2007-09-10
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT (K071565)Molnlycke Health Care Us, LLC2007-09-10
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 (K071486)Restorative Therapies, Inc.2007-09-10
CORIN ADAPTOR SLEEVE (K071471)Howmedica Osteonics Corp.2007-09-10
QUICKIE QX MANUAL FOLDING WHEELCHAIR (K072153)Sunrise Medical, Inc.2007-09-10
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) (K070694)Mike Miner2007-09-10
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K071414)Molnlycke Health Care Us, LLC2007-09-10
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS (K071507)Polymer Technology Systems, Inc.2007-09-10
I-SURGE (K071965)Satelec2007-09-10
SANDMAN INTRO (K071575)Mallinckrodt Developpement France2007-09-10
SBI TWISTOFIX (K071541)Small Bone Innovations, Inc.2007-09-10
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 (K072269)Possis Medical, Inc.2007-09-08
AQUADEX FLEXFLOW SYSTEM (K071854)Chf Solutions, Inc.2007-09-07
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM (K071348)Mennen Medical , Ltd.2007-09-07
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS (K072208)Integra LifeSciences Corporation2007-09-07
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 (K062028)Celera Diagnostics2007-09-07
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 (K071391)Philips Medical Systems, Inc.2007-09-07
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE (K071118)Ives Eeg Solutions, Inc.2007-09-07
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (K071255)Hyphen Biomed2007-09-07
JUNIPER CLN1 DERMAL COOLING DEVICE (K072152)Juniper Medical, Inc.2007-09-07
DEVILBISS INTELLIPAP MODEL DV 5 SERIES (K071689)Sunrise Medical2007-09-07
SPY FLUORESCENT IMAGING SYSTEM (K072222)Novadaq Technologies, Inc.2007-09-07
CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR (K071911)Innovision A/S2007-09-07
HONEYWELL HOMMED CENTRAL STATION 4.0 (K072272)Honeywell Hommed, LLC2007-09-07
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL (K072232)Gambro Renal Products, Inc.2007-09-07
RELIANCE S.E.P. (K071688)Reliance Orthodontic Products, Inc.2007-09-07
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE (K071145)Nipro Medical Corporation2007-09-07
NES REPROCESSED ENDOSCOPIC TROCAR (K060676)Northeast Scientific, Inc.2007-09-07
COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE (K072167)Advanced Vascular Dynamics2007-09-06
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER (K071577)Biomet Microfixation, Inc.2007-09-06
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) (K071910)Hartalega Sdn Bhd2007-09-06
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K070282)Endius, Inc.2007-09-06
VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES (K071976)Vectec2007-09-06
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 (K071221)Automedx, Inc.2007-09-06
NEXGEN PROLONG ALL-POLY PATELLA (K072281)Zimmer, Inc.2007-09-06
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS (K071196)Coeur, Inc.2007-09-06
VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK (K070895)STERIS Corporation2007-09-05
NEXGEN TRABECULAR METAL TIBIAL TRAY (K072160)Zimmer, Inc.2007-09-05
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM (K072164)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-09-05
ALPHAONE BIOFEEDBACK SYSTEM (K071661)Telediagnostic Systems, Inc.2007-09-05
ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM (K072177)Surgrx, Inc.2007-09-05
1.5T MRGFUS PELVIC COIL (K071966)Insightec-Txsonics, Inc.2007-09-05
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 (K072183)Zimmer Spine, Inc.2007-09-05
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Every clearance here is in the API, with alerts when new ones post.