Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DOCTOR SURGERY DIODE LASERS FAMILY (K102036)Lambda S.P.A.2010-09-28
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH (K101477)Glaxosmithkline Consumer Healthcare (Gskch)2010-09-28
CONSTRUX MINI PEEK SPACER SYSTEM (K101812)Orthofix, Inc.2010-09-27
MINI MAXLOCK EXTREME PLATING SYSTEM (K101962)Orthohelix Surgical Designs, Inc.2010-09-27
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100421)Tangshan Yonkshun Glove, Co., Ltd.2010-09-27
VESSEL GUARDIAN (K102136)Lexion Medical, LLC2010-09-27
CD HORIZON SPINAL SYSTEM (K091445)Medtronic Sofamor Danek2010-09-27
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM (K093047)Smith & Nephew, Inc.2010-09-27
VITOMATRIX (K091618)Orthovita, Inc.2010-09-27
PERCU-PRO GUIDEWIRE (K094062)Cardiosolutions, Inc.2010-09-27
ATEK SURGICAL GOWNS (K100971)Hangzhou Atek Medical & Textile Co., Ltd.2010-09-27
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102098)Hong DI Plastic Products Co., Ltd.2010-09-27
DIRECT CROWN NATURAL 1 (K101814)Candulor USA, Inc.2010-09-27
STALIF MIDLINE (K101301)Centinel Spine2010-09-24
NEURALMAS (K100992)Innovative Surgical Solutions, LLC ("Iss")2010-09-24
GMK REVISION KNEE SYSTEM (K102437)Medacta International S.A.2010-09-24
PATIENT MONITOR (K102040)Guangdong Biolight Meditech Co., Ltd.2010-09-24
SOCORRO SMI TUNNEL RELEASE DEVICE (K102219)Socorro Medical, Inc.2010-09-24
QUICKVUE RSV 10 (K101918)Quidel Corp.2010-09-24
FDI GLUCOSE CONTROL SOLUTIONS (K102260)Fujirebio Diagnostics,Inc.2010-09-24
ISOLED AC-POWERED LED HEADLIGHT SYSTEM (K102266)Isolux, LLC2010-09-24
ASCENT F-COAT MODEL: 006-00097 (K100540)CAO Group, Inc.2010-09-23
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE (K091561)ZOLL Medical Corporation2010-09-23
GUIDE CATHETERS AND ACCESSORIES (K101015)Thomas Medical Products, Inc.2010-09-23
ROSA SURGICAL DEVICE (K101791)Medtech S.A.S2010-09-23
AFFIRM DO DIODE LASER (K101601)Cynosure, Inc.2010-09-23
ACCUSCULPT II LASER SYSTEM (K101573)Lutronic Corporation2010-09-23
ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD (K100037)Advanced Vertebral Solutions, LLC2010-09-23
NEOWIRE PTA/PTCA GUIDEWIRE (K101729)Neometrics, Inc.2010-09-23
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (K102018)Synthes USA Products, LLC2010-09-23
ENSITE VERISMO SEGMENTATION TOOL V.2.0 (K101697)St Jude Medical2010-09-22
UROSTATION 3D PROSTATE SUITE (K100793)Koelis2010-09-22
CALGAESEAL MODEL: CAS (K101097)Bz Medical, Inc.2010-09-22
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S (K100578)Asahi Intecc Co., Ltd.2010-09-22
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 (K101761)Exactech, Inc.2010-09-21
CRITICAL CARE ASSESSMENT (K101983)Critical Patient Care, Inc.2010-09-21
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (K100479)Arthrocare Corp.2010-09-21
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K102462)STERIS Corporation2010-09-21
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES (K100845)Zimmer Spine, Inc.2010-09-21
RELINE-IT MODEL RELINE-IT (K101771)Majestic Drug Co., Inc.2010-09-20
GERATHERM UNIQUERESC (K093694)Geratherm Medical AG2010-09-20
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 (K101688)Exact Medical Manufacturing, Inc.2010-09-20
SHIMADZU COLLIMATOR R-300 (K101039)Shimadzu Corp.2010-09-20
WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N (K100969)Wmi Enterprises, LLC2010-09-20
ALBOSURE POLYESTER VASCULAR PATCH (K101740)LeMaitre Vascular, Inc.2010-09-20
E-LIGHT LINE (K092734)Espansione Marketing S.P.A2010-09-20
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 (K102356)Andon Health Co, Ltd.2010-09-20
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K102017)Siemens Medical Solutions USA, Inc.2010-09-20
EMM EQUIPMENT COVER-POLYTHYLENE (K101689)Exact Medical Manufacturing, Inc.2010-09-20
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS (K101589)Cincinnati Sub-Zero Products, Inc.2010-09-20
MODEL SB100II FINGER PULSE OXIMETER (K101568)Atlantean2010-09-20
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- (K093883)Seppim S.A.S.2010-09-20
SHAPE TO FIT COMPRESSION WEAR (K101906)Tsung Hau Technology Co., Ltd.2010-09-17
ACUTE INNOVATIONS STERNAL FIXATION SYSTEM (K101170)Acute Innovations, LLC2010-09-17
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 (K102353)Andon Health Co, Ltd.2010-09-17
CRYO-TOUCH II (K102021)Myoscience, Inc.2010-09-17
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U (K100657)Kci USA, Inc. (Kinetic Concepts, Inc.)2010-09-17
REVIVATOR (K094003)Hersill, S.L.2010-09-17
GC FUJI TEMP (K101420)GC America, Inc.2010-09-17
E-BASIC SINGLE BREAST PUMP (K101157)Mapa GmbH2010-09-17
ULTRASEAL ID (K101245)Ultradent Products, Inc.2010-09-17
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (K101366)Chromogenex Technologies, Ltd.2010-09-17
CO2 LASER SYSTEM (K101555)Advanced Technology Laser Co., Ltd.2010-09-17
BABY QUASAR (K091467)Silver Bay, LLC2010-09-17
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT (K100787)Smith & Nephew, Inc.2010-09-17
MYRAY HYPERION (K101661)Cefla Dental Group2010-09-16
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK (K101129)Respironics, Inc.2010-09-16
PROPATCH SOFT TISSUE REPAIR MATRIX (K101587)Cryolife, Inc.2010-09-16
ITOTAL CR KNEE REPLACEMENT SYSTEM (K094050)Conformis, Inc.2010-09-16
ECO SUPERGEL (K101429)Ceracarta Spa2010-09-15
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A (K101968)St Jude Medical2010-09-15
IMIX PANORAD AND SOMARAD (K101435)Imix Adr Finland OY2010-09-15
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY (K102291)Covidien2010-09-15
ZOLL PROPAQ M (K102174)Zoll Medical Corporation, World Wide Headquarters2010-09-15
CEROS TCP GRANULES (K101426)Mathys, Ltd.2010-09-15
MEPILEX BORDER AG DRESSING (K100029)Molnlycke Health Care2010-09-15
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM (K100726)Biolitec, Inc.2010-09-15
EMBRACE (K101373)Izi Medical Products, Inc.2010-09-15
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION (K093254)Abbott Medical Optics, Inc.2010-09-15
2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM (K101536)Synthes (Usa), LLC2010-09-15
TRIMED X-FIX (K101375)TriMed, Inc.2010-09-15
RTVUE MODEL RTVUE 100 (K101505)Optovue, Inc.2010-09-15
TAPERED SCREW-VENT T IMPLANT (K101977)Zimmer Dental, Inc.2010-09-14
SMITH & NEPHEW INSTRUMENT TRAYS (K092551)Smith & Nephew Inc., Endoscopy Div.2010-09-14
ST AIA-PACK CYSTATIN C, MODEL 025217 (K093960)Tosoh Bioscience, Inc.2010-09-14
CABLECAP MODEL: WLF, STZ, ACM (K101496)Sensormed2010-09-14
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET (K101976)Omni Life Science, Inc.2010-09-14
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (K101064)Bredent GmbH & Co. KG2010-09-14
INTELLIWAVE3 (K100221)Art Optical Contact Lens, Inc.2010-09-14
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK (K100727)Bio-Rad, Diagnostics Grp.2010-09-14
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER (K101824)Amsino International, Inc.2010-09-13
RXPEAKFLOW (K101380)Noble Marketing2010-09-13
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 (K102173)Moldex/Metric, Inc.2010-09-13
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM (K100017)Euroimmun Us, Inc.2010-09-13
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (K100899)Keymed (Medical & Industrial Equipment), Ltd.2010-09-13
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE (K101783)New Star Lasers, Inc.2010-09-13
TRANSCORP ACIF SYSTEM (K092794)Transcorp, Inc.2010-09-13
CLEARARCH (K101676)Ormco Corp.2010-09-13
STLASE DIODE LASER (K094049)Dental Photonics, Inc.2010-09-10
BLOOD PRESSURE METER, MODEL CH-658 (K102303)Citizen Systems Japan Co., Ltd.2010-09-10
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Every clearance here is in the API, with alerts when new ones post.