Atlas FDA

2014

3,202 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AngioVac Cannula (K142593)AngioDynamics, Inc.2014-11-12
HEALTH EXPERT ELCTRONIC STIMULATOR (K133929)Shenzhen Osto Technology Company Limited2014-11-12
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM (K141571)Orthofix Srl2014-11-12
Coronis Fusion 4MP LED (K143157)Barco N.V.2014-11-12
Zimmer Plates and Screws (ZPS), Forte Screws (K142836)Zimmer, Inc.2014-11-12
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) (K143076)Jvckenwood Corporation2014-11-12
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS (K141457)Dentium Co., Ltd.2014-11-12
EIDON (K142047)Centervue S.P.A.2014-11-12
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US (K142903)Neosurgical, Ltd.2014-11-12
KIMGUARD SMART-FOLD STERILIZATION WRAP (K140963)Kimberly-Clark Corp.2014-11-10
DENALI 501CEMENT (K141503)Denali Corporation2014-11-10
LEAF PATIENT MONITORING SYSTEM (K141877)Leaf Healthcare, Inc.2014-11-10
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K140961)Stryker Trauma AG2014-11-10
YEESCOPE LARYNGOSCOPES (K140951)Yeescope Pty. , Ltd.2014-11-10
PANTHEON ELECTROSTIMULATOR (K133980)Pantheon Research2014-11-07
Power Twin21-50/Power Twin21-100 (K142215)Livetec GmbH2014-11-07
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K141771)Nanostring Technologies, Inc.2014-11-07
INNOVASIS CRANIAL SYSTEM (K141644)Innovasis, Inc.2014-11-07
EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments (K142550)Microport Orthopedics, Inc.2014-11-07
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS (K140732)Candela Corp.2014-11-07
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING (K143001)Argentum Medical2014-11-07
ZANZA-CLICK (DEN130019)Tecnimed S.R.L.2014-11-07
ZAP-IT! (DEN100024)Ecobrands , Ltd.2014-11-07
ENCORE HUMERAL SHOULDER STEM (K141990)Encore Medical L.P.2014-11-07
PUREFILL OXYGEN COMPRESSOR (K141967)Inovo, Inc.2014-11-07
MIDLINE II TI (K141942)Centinel Spine, Inc.2014-11-07
SMR 40MM GLENOSPHERE (K142139)Lima Corporate S.P.A.2014-11-07
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 (K140389)Entrotech Life Sciences, Inc.2014-11-07
INS HILDEN TIBIAL ARZZT (K133166)Truemed Group, LLC2014-11-06
ZOLL E SERIES ALS (K140502)ZOLL Medical Corporation2014-11-06
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K141668)Integra LifeSciences Corporation2014-11-06
NAKOMA ACP (K141993)Alliance Partners, LLC2014-11-06
LINK MP RECONSTRUCTION PROSTHESIS (K142187)Waldemar Link GmbH & Co. KG2014-11-06
CUTERA PICOSECOND LASER SYSTEM (K140727)Cutera, Inc.2014-11-06
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED (K140130)Encore Medical L.P.2014-11-06
YONGFA (K140246)Yongfa Glove Co., Ltd.2014-11-06
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM (K140355)Terang Nusa Sdn Bhd2014-11-06
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator (K142640)Bio Compression Systems, Inc.2014-11-06
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K141674)Integra LifeSciences Corporation2014-11-06
NIOX VERO AIRWAY INFLAMMATION MONITOR (K133898)Aerocrine AB2014-11-06
YONGHE (K140244)Yonghe Plastic Products Co., Ltd.2014-11-06
FlexCath Select Steerable Sheath (10 French) (K142684)Medtronic Cryocath, LP2014-11-06
OBSIDIAN PRESS (ALL CERAMIC AND POM) (K141887)Prismatik Dentalcraft, Inc.2014-11-06
STIMPOD ST2-3010 NERVE STIMULATOR (K140853)Xavant Technology (Pty), Ltd.2014-11-06
ADVANTAGE (K141555)Lutronic Corporation2014-11-06
IG_PLEX CELIAC DGP PANEL (K140691)Sqi Diagnostics Systems, Inc.2014-11-06
CAPRI (K142016)K2m, Inc.2014-11-06
Acrobat Calibrated Tip Wire Guide (K142950)Wilson-Cook Medical, Inc.2014-11-05
MAXAN ANTERIOR CERVICAL PLATE SYSTEM (K133518)Biomet Spine (Aka Ebi, LLC)2014-11-05
SPEX SUPPORT CATHETER (K141649)Reflow Medical2014-11-05
E-Shield Multi-paried Subdermal Needle Electrodes (K142470)Neuroinvent, Inc.2014-11-05
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP (K141909)Collagen Matrix, Inc.2014-11-05
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 (K142020)Biomonde2014-11-05
ICE ZIRKON TRANSLUZENT (K132230)Zirkonzahn Srl2014-11-05
GUIDOSS (K133507)Nibec Co., Ltd.2014-11-05
PASS LP SPINAL SYSTEM (K140738)Medicrea International2014-11-04
LIAT STREP A ASSAY (K141338)Iquum, Inc.2014-11-04
DUREX EMBRACE PERSONAL LUBRICANT (K140193)Reckitt Benckiser, LLC2014-11-04
Unimed Disposable ECG lead wires (K142489)Unimed Medical Supplies, Inc.2014-11-04
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM (K141676)Renovis Surgical Technologies, Inc.2014-11-04
STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR (K141238)Sterilucent, Inc.2014-11-03
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K141700)Genoray Co., Ltd.2014-10-31
STERILUCENT PROCESS CHALLENGE DEVICE (K141312)Sterilucent, Inc.2014-10-31
NOVABONE BIOACTIVE STRIP (K141207)Novabone Products, LLC2014-10-31
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE (K141126)Unisis Corp.2014-10-31
Bard RiteCath Intermittent Urinary Catheter (K142575)C.R. Bard, Inc.2014-10-31
TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM (K140293)Adin Dental Implants Systems , Ltd.2014-10-31
Sternal Closure System (K142484)Jace Medical, LLC2014-10-31
SoftVue (K142517)Delphinus Medical Technologies, Inc.2014-10-31
NAWALUTION SKIN AND WOUND CLEANSER (K141660)Nawa Heilmittel GmbH2014-10-31
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER (K140464)Sterilucent, Inc.2014-10-31
IMPLANT STUDIO (K141570)3Shape Medical A/S2014-10-31
IQQA-BODYIMAGING SOFTWARE (K141745)Edda Technology2014-10-31
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES (K142088)Grandway Technology (Shenzhen) Limited2014-10-31
NS3000 Holmium Laser System (K142286)New Star Lasers, Inc.2014-10-31
SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D (K141941)Stryker Corporate2014-10-31
T:SLIM INSULIN DELIVERY SYSTEM (K141758)Tandem Diabetes Care, Inc.2014-10-31
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K140008)Terumo Cardiovascular Systems Corporation2014-10-31
RAPIDRESULTS (K141881)Ramsoft, Inc.2014-10-31
NOVAPACS (K132853)Novarad Corp.2014-10-30
Pico Way Laser System (K142372)Candela Corpation2014-10-30
VELASII THERAPY LASER SYSTEM (K142078)Aspen Laser Systems, LLC2014-10-30
ELIA SCL-70S IMMUNOASSAY (K140493)Phadia GmbH2014-10-30
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens (K142851)Unilens Corp., USA2014-10-30
ASTROGLIDE SENSUAL STRAWBERRY (K140590)Biofilm, Inc.2014-10-30
ISO-GARD MASK (K142138)Teleflexmedical, Inc.2014-10-30
Premium Surgiclip III (K142869)Covidien2014-10-30
VC150 VITAL SIGNS MONITOR (K133810)Innokas Yhtyma2014-10-30
J2I IMPLANT SYSTEM (K140052)Kj Meditech Co., Ltd.2014-10-30
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material (K142878)Siemens Healthcare Diagnostics, Inc.2014-10-30
Miltex N-Tralig Intraligamentary Syringe (K142414)Integra LifeSciences Corporation2014-10-30
Site-Rite 6 Ultrasound System with Pinpoint GT Technology (K142443)C.R. Bard, Inc.2014-10-30
KJ EXTERNAL IMPLANT SYSTEM (K140051)Kj Meditech Co., Ltd.2014-10-30
Ascendra Balloon Aortic Valvaloplasty Catheter (K142199)Edwards Lifesciences2014-10-29
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) (K142864)Siemens Healthcare Diagnostics, Inc.2014-10-29
cryoICE croablation probe (K142441)AtriCure, Inc.2014-10-29
Leo Minor (K142984)Sunnex, Inc.2014-10-29
AIS MODULIFT VBR SYSTEM (K142150)Aesculap Implant System, Inc.2014-10-29
REBOSSIS (K142090)Orthorebirth Co., Ltd.2014-10-29
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM (K142050)Nu Vasive, Incorporated2014-10-29
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Every clearance here is in the API, with alerts when new ones post.