Atlas FDA

2011

3,124 FDA 510(k) clearances · Clearance year

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RecordFirmDate
N-FORCE FIXATION SYSTEM (K102528)Innovision, Inc.2011-07-28
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE (K111191)Wet Nose Technologies, LLC2011-07-28
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT (K111400)Exactech, Inc.2011-07-28
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR (K111000)Parcus Medical, LLC2011-07-28
BD AUTOSHIELD DUO PEN NEEDLE (K110703)Becton, Dickinson and Company2011-07-27
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY (K110546)Derma Sciences, Inc.2011-07-27
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K111752)Shandong Jianhong New Material Company2011-07-27
TISSUE SAMPLING NEEDLE (K103694)United States Endoscopy Group, Inc.2011-07-27
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF (K111972)Medtronic, Inc.2011-07-27
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (K111493)Nidek Co., Ltd.2011-07-27
AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, (K110156)Contec Medical System Co., Ltd.2011-07-27
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI (K111517)Pharmajet, Inc.2011-07-27
ADVANCIS ACTIVON TUBE (K101114)Advancis Medical2011-07-26
PATCH, PLEDGET AND INTRACARDIAC (K111187)Cormatrix Cardiovascular, Inc.2011-07-26
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM (K111388)Cardiovascular Systems, Inc.2011-07-26
LOGIQ S8 (K111582)GE Healthcare2011-07-26
PICA WHOLE-BODY MRI SYSTEM (K110942)Time Medical Limited2011-07-26
APEX SPINE SYSTEM (K110906)Spinecraft, LLC2011-07-26
INTEGRATED INNOVA - S5I SYSTEM OPTION (K111209)GE Healthcare2011-07-26
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM (K110990)Gold Standard Orthopedics, LLC2011-07-25
DIXTAL DZ-4100 SERIES PULSE OXIMETER (K103285)Dixtal Medical, Inc.2011-07-25
CXI TRIFORCE (K111263)Cook Incorporated2011-07-25
VISION ONE LASER SYSTEM (K111213)Lumenis, Inc.2011-07-25
3.7MM/5.0MM DYNAMIC LOCKING SCREW (K110592)Synthes USA2011-07-25
CIRCUMAURAL ADHESIVE REPLACEMENT (K111555)R & D Medical Products, Inc.2011-07-25
ACRYLIC HERBST APPLIANCE (K111009)Embassy Dental Laboratory2011-07-22
VENUS CERVICAL SPINAL FIXATION SYSTEM (K103414)L&K BIOMED Co., Ltd.2011-07-22
CUFF SENTRY (K102674)Ventlab Corp.2011-07-22
MAESTRO WRIST PLATING SYSTEM (K110271)Biomet Manufacturing Corp2011-07-22
ENDOFLIP GASTRIC TUBE (K110529)Crospon, Ltd.2011-07-22
CERVICAL CAGE (K110915)Eisertech, LLC2011-07-22
LOGIQ E9 (K110943)GE Healthcare2011-07-22
RE / STASIS (TM) GINGIVAL RETRACTION PASTE (K111348)Centrix, Inc.2011-07-22
SLIM E30 II CO2 LASER (K110984)Lasering S.R.L.2011-07-22
MP 719 (K111524)Marine Polymer Technologies, Inc.2011-07-22
MYLABSEVEN, MYLABALPHA (K111302)Esaote, S.p.A.2011-07-22
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM (K111866)Nuvasive, Inc.2011-07-22
ROTOGRAPH EVO 3D (K111152)Villa Sistemi Medicali S.P.A.2011-07-22
APNEA GUARD (K111110)Advanced Brain Monitoring, Inc.2011-07-22
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. (K111631)Depuy Mitek, A Johnson & Johnson Company2011-07-22
CARDIAC TRIGGER MONITOR (K110987)Ivy Biomedical Systems, Inc.2011-07-22
COREN TOTAL HIP SYSTEM (K103431)Corentec Co., Ltd.2011-07-21
EXPLOR RADIAL HEAD PLATING SYSTEM (K110201)Biomet, Inc.2011-07-21
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT (K111280)Kci USA, Inc.2011-07-21
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE (K111750)Angioslide, Ltd.2011-07-21
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE (K101453)Obi Biologics, Inc.2011-07-21
ELECSYS T3 CALCHECK 5 (K111552)Roche Diagnostics2011-07-21
REXIOUS SPINAL FIXATION SYSTEM (K111362)Dio Medical Co., Ltd.2011-07-21
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K110970)Ppp Medical and Safety Products Company Limited2011-07-21
CI-SNAP WOUND CARE SYSTEM (K111006)Spiracur, Inc.2011-07-21
INFUSION SET FOR POWERPICC SOLO 2 CATHETER (K102405)C.R. Bard, Inc.2011-07-21
DSC/ALF SPINAL SYSTEM (K101886)Sintea Plastek, LLC2011-07-21
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) (K110966)Ppp Medical and Safety Products Company Limited2011-07-21
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM (K111801)Zyga Technology, Inc.2011-07-21
GENESYS SPINE TILOCK SYSTEM (K103671)Genesys Spine2011-07-21
SLEEPMINDER BREATHING FREQUENCY INDICATOR (K103631)Biancamed Limited2011-07-21
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 (K103831)Depuy Mitek, A Johnson & Johnson Company2011-07-21
METASURG DIGIFUSE IMPLANT (K111536)Metasurg2011-07-21
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM (K110320)Biomet Manufacturing Corp2011-07-21
ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER (K100305)Icotec2011-07-21
AIDITE ZIRCONIA DENTAL CERAMICS (K111291)Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.2011-07-20
GE DATEX-OHMEDA AISYS (K110213)Datex-Ohmeda, Inc.2011-07-20
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF (K103745)Glaxosmithkline Consumer Healthcare (Gskch)2011-07-20
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) (K111061)Encore Medical L.P.2011-07-20
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE (K111598)Lpl (Hui Zhou) Glove Co., Ltd.2011-07-20
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 (K111399)Arthrocare Corp.2011-07-20
MICROSCAN (R) MICROSTREP PLUS (R) PANELS (K111205)Siemens Healthcare Diagnostics, Inc.2011-07-20
STERI-DENT, STERI-SURE (K110867)Cpac, Inc.2011-07-20
PATHWAY MODEL 07XXXX (K111774)Custom Spine2011-07-20
AXXENT RADIATION SHIELD - RIGID (K111299)Xoft, an Icad Company2011-07-20
AVIE A1C TEST SYSTEM (K093548)Mec Dynamics Corp2011-07-20
AAP CANNULATED SCREWS (K111316)Aap Implantate AG2011-07-20
PATIENT MONITOR (K110922)Edan Instruments, Inc.2011-07-20
SEVOFLURANE VAPORIZER ADAPTOR (K110608)Piramal Critcal Care, Inc (Formerly Minrad, Inc)2011-07-20
COMMUNIFY PACS VIEWER (K110797)Flying Squirrel Storage, LLC2011-07-20
CRAG LATERAL FLOW ASSAY (CRAG LFA) (K102286)Immuno-Mycologics, Inc.2011-07-20
HEMI IMPLANT; MINI HEMI IMPLANT (K102401)Vilex, Inc.2011-07-20
OPTIMA CT660 (K110227)Ge Medical Systems, LLC2011-07-20
PLATEAU SPACER SYSTEM (K111835)Life Spine, Inc.2011-07-19
ABL90 (K111897)Radiometer Medical Aps2011-07-19
DOLPHIN 3 FLUID MANAGEMENT SYSTEM (K110852)Gyrus Acmi, Inc.2011-07-19
MEDLINE VESSEL CANNULA (K111147)Medline Industries, Inc.2011-07-19
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K (K111495)Wilson-Cook Medical, Inc.2011-07-19
ENTROPY EASYFIT SENSOR (K103129)GE Healthcare2011-07-19
MINI TELEMETRY SYSTEM (K110556)Wipro GE Healthcare Private, Ltd.2011-07-19
MOBILEDIAGNOST WDR (K111725)Sedecal., Sa.2011-07-19
BD INSYTE AUTOGUARD BC (K110443)Becton, Dickinson & CO2011-07-19
NEURON MAX SYSTEM (K111380)Penumbra, Inc.2011-07-19
STAXXSD SYSTEM (K111469)Spine Wave, Inc.2011-07-19
BEL-CAT (K101181)Takara Belmont Corp.2011-07-19
OPTIMA XR120 (K111304)Ge Medical Systems, LLC2011-07-19
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 (K101407)Immuno-Mycologics, Inc.2011-07-19
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL (K103676)Fujirebio Diagnostics,Inc.2011-07-19
CANDELA GENTLELASE FAMILY OF LASERS (K111144)Candela Corp.2011-07-18
CAPSTONE R SPINAL SYSTEM (K103731)Medtronic Sofamor Danek2011-07-18
DOMAIN SURGICAL SYSTEM (K110439)Domain Surgical, Inc.2011-07-18
REPROCESSED ENDOSCOPIC TROCARS (K111002)Sterilmed, Inc.2011-07-18
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR (K110956)Medivance, Inc.2011-07-18
REPROCESSED ELECTROSURGICAL INSTRUMENT (K110189)Ascent Healthcare Solutions2011-07-18
G-SCAN (K111803)Esaote, S.p.A.2011-07-15
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Every clearance here is in the API, with alerts when new ones post.