Atlas FDA

2009

3,008 FDA 510(k) clearances · Clearance year

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RecordFirmDate
YIELD MINI DOPPLER SYSTEM (K090743)Broncus Technologies, Inc.2009-04-03
LIGHTSTREAM LOW LEVEL LASER (K081166)Solica Corporation2009-04-03
MD2000A VITAL SIGN MONITOR, MODEL MD2000A (K083466)Beijing Choice Electronic Technololgy Co., Ltd.2009-04-03
V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710 (K090805)Pride Mobility Products Corp.2009-04-03
REGENEREX PATELLA COMPONENTS (K083782)Biomet Manufacturing Corp2009-04-03
APK SPO2 PULSE OXIMETER SENSOR (K082846)APK Technology Co., Ltd.2009-04-03
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA (K082470)Inter-Med, Inc.2009-04-03
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE (K090327)Wear Safe (Malaysia) Sdn. Bhd.2009-04-03
PREMISE MODIFIED (K090292)Kerr Corp.2009-04-03
INFANT CARDIAC ARRAY (K083539)Advanced Imaging Research, Inc.2009-04-03
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES (K090352)Covidien2009-04-03
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C (K082327)Somanetics Corp.2009-04-03
MAK OSS KNEE FEMORAL COMPONENTS (K083779)Biomet Manufacturing Corp2009-04-03
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (K090398)Ventus Medical, Inc.2009-04-03
ZETAJET (K090003)Bioject, Inc.2009-04-02
COOK MREYE EMBOLIZATION COILS (K090624)Cook, Inc.2009-04-02
STIWELL MED4 (K080950)Otto Bock, Austria GmbH2009-04-02
BLACK WIDOW ANTERIOR BUTTRESS PLATE (K081770)Omni Surgical, L.P.2009-04-02
REPLICATION MEDICAL VESSEL GUARD (K082782)Replication Medical, Inc.2009-04-02
INTERGRO DBM (K082793)Biomet Spine2009-04-02
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP (K090713)American Medical Systems, Inc.2009-04-02
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) (K083386)Siemens Healthcare Diagnostics2009-04-02
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 (K083693)Covidien, Formerly Nellcor Puritan Bennett, Inc.2009-04-02
ASAP WOUND DRESSING GEL (K082333)American Biotech Labs2009-04-02
ATMOS S041 WOUND (K090130)Atmos, Inc.2009-04-02
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (K083482)Cook Vascular, Inc.2009-04-02
NEOSALUS CREAM (K090585)Quinnova Pharmaceuticals2009-04-02
LNCS OXIMETRY SENSORS (K083622)Masimo Corporation2009-04-02
SPINESMITH CYNCH SPINAL SYSTEM (K090376)Spine Smith Partners L.P.2009-04-01
NAVIGATOR APPLICATIONS SUITE (K083098)GE Healthcare Finland Oy2009-04-01
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (K090163)St Jude Medical2009-04-01
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM (K090759)Biodrain Medical, Inc.2009-04-01
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C (K083820)Vasomedical, Inc.2009-04-01
SURGYBONE (K083569)Silfradent S.R.L.2009-04-01
XIA 3 SPINAL SYSTEM (K083393)Stryker Spine2009-04-01
ALCO TUBE PLUS (K082080)Alcotest Quebec2009-04-01
PK-141 PATIENT CABLE (K083674)Biotronik, Inc.2009-04-01
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM (K090047)Synthes (Usa)2009-04-01
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY (K083524)Siemens Medical Solutions USA, Inc.2009-04-01
SPINE & TRAUMA ICT (K083310)Brainlab AG2009-04-01
REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K090323)Ascent Healthcare Solutions2009-04-01
SOPRO 184 CAMERA (K082796)Sopro2009-04-01
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (K081527)Millipore Corporation2009-04-01
ACUSON P50 ULTRASOUND SYSTEM (K083114)Siemens Medical Solutions USA, Inc.2009-03-31
DRILL FREE MMF SCREW (K083432)KLS Martin L.P.2009-03-31
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 (K090026)Hem Con Medical Technologies, Inc.2009-03-31
OKAMOTO ULTRA THIN (K090259)Okamoto USA, Inc.2009-03-31
VITABLOCS, MODEL VX55-**** (K090644)Vita Zahnfabrik H.Rauter GmbH & Co.2009-03-31
ASCEND (K083722)Caldera Medical, Inc.2009-03-31
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM (K090722)Shape Medical Systems, Inc.2009-03-31
PRELUDE ONE (K090106)Danville Materials, Inc.2009-03-31
AUTOSPECT (K090403)Philips Medical Systems (Cleveland), Inc.2009-03-31
LIFEDOP MODEL, L350R (K090499)Summit Doppler Systems, Inc.2009-03-31
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING (K083446)Ziosoft, Inc.2009-03-31
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 (K090223)Icad, Inc.2009-03-31
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS (K090492)DePuy Orthopaedics, Inc.2009-03-31
NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER (K090553)Naviscan, Inc.2009-03-31
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 (K080852)KARL STORZ Endoscopy-America, Inc.2009-03-30
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, (K083784)Vascular Solutions, Inc.2009-03-30
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR (K083487)Siemens Healthcare Diagnostics2009-03-30
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P (K082719)NIKKISO CO., LTD.2009-03-30
EPTFE SLFTM SPIRAL VASCULAR GRAFT (K083169)Tayside Flow Technologies Limited2009-03-30
THE WAND MICROACCESS SAFETY INTRODUCER (K090372)Access Scientific, Inc.2009-03-30
SENTINEL, MODEL SP-001 (K082582)C-Rad Positioning AB2009-03-30
SPI VARIOMULTI ANGLED ABUTMENT (K090153)Thommen Medical AG2009-03-27
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY (K090410)New Star Lasers, Inc.2009-03-27
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER (K090512)C.R. Bard, Inc.2009-03-27
KIMGUARD ONE-STEP STERILIZATION WRAP (K082177)Kimberly-Clark Corp.2009-03-27
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE (K090649)Virtual Radiologic Corporation2009-03-27
SYNTHASOME X-REPAIR (K083307)Synthasome, Inc.2009-03-27
THEKEN ATOLL OCT SPINAL SYSTEM (K083863)Theken Spine, LLC2009-03-27
GORE BIO-A FISTULA PLUG (K083266)W. L. Gore & Associates, Inc.2009-03-27
BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI (K083869)Btlock Srl2009-03-27
HYLATOPIC EMOLLIENT FOAM (K083024)Collegium Pharmaceutical Incorporated2009-03-27
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) (K083161)Conmed Linvatec2009-03-27
UA-CELLULAR FOR IQ (K090201)Streck2009-03-27
TRUEBALANCE BLOOD GLUCOSE SYSTEM (K090495)Home Diagnostics, Inc.2009-03-27
ONEPLANT DENTAL IMPLANT SYSTEM (K081748)Warantec Co., Ltd.2009-03-27
RELIANCE SPINAL SCREW SYSTEM (K081978)Reliance Medical Systems, LLC2009-03-26
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM (K083020)Stryker Corp.2009-03-26
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY (K090659)Medtronic, Inc.2009-03-26
C. DIFF QUIK CHEK COMPLETE (K082499)Techlab, Inc.2009-03-26
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K082662)Surgical Devices, Tyco Healthcare Group LP2009-03-26
CRITICOOL (K083662)Mtre Advanced Technology , Ltd.2009-03-26
THE BELMONT BUDDY LITE FLUID WARMER (K090508)Belmont Instrument Corp.2009-03-26
MORTARA STRESS ECHO BED (K082967)Medical Positioning, Inc.2009-03-26
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (K082227)Sebia2009-03-26
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 (K090112)Medtronic Powered Surgical Solutions2009-03-26
EK/P. AERUGINOSA PNA FISH (K081433)Advandx, Inc.2009-03-26
HYDRORISE AND HYDROSYSTEM (K083739)Zhermack S.P.A.2009-03-26
AOS PROXIMAL HUMERAL NAIL (K090478)Advanced Orthopaedic Solutions, Inc.2009-03-26
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247 (K090536)Taidoc Technology Corporation2009-03-26
COALITION SPACER (K083389)Globus Medical, Inc.2009-03-26
FORUM (K090439)Carl Zeiss Meditec, Inc.2009-03-25
EVERON (K082465)Earlysense, Ltd.2009-03-25
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 (K083234)Kimberly-Clark Corp.2009-03-25
THE MEDCOMP .010 VASCULAR GUIDEWIRES (K081775)Medcomp2009-03-25
DISCOVERY ELBOW - X-SMALL (K090473)Biomet Manufacturing Corp2009-03-25
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR (K081946)Quantel Medical2009-03-25
I_OPEN 0.4T (K090433)Beijing Wandong Medical Equipment Co., Ltd.2009-03-25
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Every clearance here is in the API, with alerts when new ones post.