Atlas FDA

2014

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
2300 SERIES MGO PORTABLE OXYGEN (K134023)Ultra Electronics Limited Precision Air & Land SY2014-04-25
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM (K134045)Zimmer Dental, Inc.2014-04-25
MTA FILLAPEX (K140247)Angelus Industria DE Productos Odontologicos SA2014-04-25
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK (K140764)Bio-Rad Laboratories2014-04-25
GEL-BEAD EMBOLIZATION SPHERES (K133237)Vascular Solutions, Inc.2014-04-25
SMARTTOUCH (K133951)Nexus6, Ltd.2014-04-25
THE MOSES ELITE APPLIANCE (K132933)Allen J. Moses, Dds, Ltd.2014-04-25
ELECTRIC BREAST PUMP (K132882)Shantou Xinghe Electrical Apparatuses Co., Ltd.2014-04-24
FLUID LEVEL MONITOR (K133870)Coleman Laboratories2014-04-24
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K132433)Acclarent, Inc.2014-04-24
COUNTER OTC TENS DEVICE (K132993)Counter Scientific Development (Gz), Ltd.2014-04-24
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO (K134013)Bio-Rad Laboratories2014-04-24
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB (K140080)Codman & Shurtleff, Inc.2014-04-24
PINOOK STIMULATOR (K132563)Pinook USA2014-04-24
NEURAGEN 3D (K130557)Integra LifeSciences Corporation2014-04-24
QUICK RELAX PRO (K131956)Healthcare Innovations, LLC2014-04-24
MONOFILAMENT POLYPECTOMY SNARE (K140763)United States Endoscopy2014-04-24
DIODE LASER FOR HIAR REMOVAL (K131838)Beijing Honkon Technologies Co., Ltd.2014-04-24
POLARIS SPINAL SYSTEM -TRANSLATION SCREW (K140123)Ebi, LLC2014-04-24
DISCOVERY IGS 740 (K133278)GE Medical Systems SCS2014-04-24
DX3000-L (K133007)Dexcowin Co., Ltd.2014-04-24
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K131525)Defibtech, LLC2014-04-24
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) (K140561)Xlumena, Inc.2014-04-23
XQ-1 INCUBATOR (K133742)At Medical Uab2014-04-23
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC (K140445)Imaging Sciences International, LLC2014-04-23
CENTERVUE MACULAR INTEGRITY ASSESSMENT (K133758)Centervue S.P.A.2014-04-23
NASAL MASK, NASAL MASK, FULL FACE MASK (K133009)BMC Medical Co., Ltd.2014-04-23
FORTRESS PEDICLE SCREW SYSTEM (K140010)Spineology, Inc.2014-04-23
PATIENT MONITOR (K132077)Advanced Instrumentations, Inc.2014-04-23
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS (K132595)Ontex Bvba2014-04-23
ACCUTIP COVER (K132549)Accutome, Inc.2014-04-23
EUM 100PRO (K131889)Promedic, Inc.2014-04-23
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K133897)Infraredx, Inc.2014-04-23
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE (K140147)Bio-Medical Carbon Technology Co., Ltd.2014-04-22
MEDSOURCE SELECTABLE IV SET (K140442)Medsource International, LLC2014-04-22
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF (K133829)Vivonic GmbH2014-04-22
HEPATIC VCAR (K133649)GE Medical Systems SCS2014-04-22
INSTINCT; PLAIN, DOTTED, ULTRA THIN (K132390)Profilatex, S.A. DE C.V.2014-04-22
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 (K133761)Toshibamedical Systems Corporation2014-04-22
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING (K140560)Ethicon Endo-Surgery, LLC2014-04-22
ENVOY GUIDING CATHETER (K140307)Codman & Shurtleff, Inc.2014-04-21
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (K140761)Carefusion 2200, Inc.2014-04-21
ALAMO T (K140303)Alliance Partners, LLC2014-04-21
COMPASS CT, COMPASS CT PORT (K133624)Mirador Biomedical2014-04-18
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY (K133597)Cook, Inc.2014-04-18
ERGONOMIC PRODUCTS WORKSTATION (K132315)Ergonomic Products, Inc.2014-04-18
PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) (K132075)Mindray North America2014-04-18
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM (K132406)Infopia Co, Ltd.2014-04-18
MCKESSON CARDIOLOGY ECG MOBILE (K133534)Mckesson Israel , Ltd.2014-04-18
ORTHOSORB LS (K140625)Biomet, Inc.2014-04-18
JULIET OL (K140474)Spineart2014-04-18
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING (K133998)Angioscore, Inc.2014-04-18
P-POD (K133397)P-Pod2014-04-18
MITEK ARTHROSCOPES (K133941)Medos International SARL2014-04-18
ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES (K131612)GS Medical Co., Ltd.2014-04-18
GENTLECARE AR APPLICATOR (K133922)Gc Medtech, LLC2014-04-18
GALAXY CO2 LASER SYSTEM (K133915)Beijing Toplaser Technology Co., Ltd.2014-04-18
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER (K132679)Galemed Corp.2014-04-18
MASTERGRAFT PUTTY, MASTERGRAFT STRIP (K140375)Medtronic Sofamor Danek USA, Inc.2014-04-18
FLIP INTRODUCER ACCESS KIT (K132789)Vascular Solutions, Inc.2014-04-17
HC-1 AND HC-1 CLASSIC (K131852)Transcendencias Comerciales SL Transcom2014-04-17
SMART (SMART-D, SMART-DX) (K131660)Bts S.P.A.2014-04-17
NUFACE MINI DEVICE (K133823)Carol Cole Company2014-04-17
ZIP MIS INTERSPINOUS FUSION SYSTEM (K140715)Aurora Spine, Inc.2014-04-17
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (K131189)Beckman Coulter, Inc.2014-04-17
DESTINO TWIST, STEERABLE GUIDING SHEATH (K140406)Oscor, Inc.2014-04-17
VARIAX 2 SYSTEM (K140769)Stryker Trauma AG2014-04-17
NEOV DIODE LASER FAMILY (K133006)G.N.S Neolaser , Ltd.2014-04-17
INITARY BETTER BLADDER-PEDIATRIC (K140321)Circulatory Technology, Inc.2014-04-17
PARALOCK PLATING SYSTEM / TUFFNEK SCREW (K140397)Paragon 282014-04-17
ICONN ANSWER SUTURE ANCHOR (K132724)Iconn Orthopedics, LLC2014-04-17
Q-STATION (K140808)Philips Ultrasound, Inc.2014-04-17
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE (K140495)Boston Scientific Corp2014-04-17
AIS MODULIFT VBR SYSTEM (K133802)Aesculap Implant System, Inc.2014-04-17
SPEED ARC (K133270)Biomedical Enterprises, Inc.2014-04-17
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW (K133421)Straumann USA, LLC2014-04-17
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES (K131962)Intuitive Surgical, Inc.2014-04-17
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) (K132547)Monarch Medical Technologies2014-04-17
ENCORE 26 ADVANTAGE KIT (K140745)Boston Scientific Corp2014-04-17
ADVATX (K132976)Advalight Aps2014-04-17
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM (K133522)Bionime Coporation2014-04-17
SOMATOM FORCE (K133589)Siemens Medical Solutions USA, Inc.2014-04-17
FREELITE HUMAN LAMBDA FREE KIT (K140396)The Binding Site Group , Ltd.2014-04-16
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION (K133783)Ameriwater2014-04-16
TRUEPATH CTO DEVICE (K140288)Boston Scientific Corp2014-04-16
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] (K133791)Sterngold Dental, LLC2014-04-16
LYRA DIRECT STREP ASSAY (DEN140005)Quidel Corporation2014-04-16
PVMED DDR 2430T (K133524)Portavision Medical, LLC2014-04-16
INSERTION TOOL (K140673)Boston Scientific Corp2014-04-16
INTESS CERVICAL CAGE SYSTEM (K133815)Kalitec Direct, LLC2014-04-16
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS (K133707)Origio A/S2014-04-16
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS (K140664)The Binding Site Group , Ltd.2014-04-16
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (K140639)Hitachi Aloka Medical, Ltd.2014-04-16
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL (K132620)Pan Medical , Ltd.2014-04-16
ROTATING ADAPTERS (K140475)Merit Medical Systems, Inc.2014-04-16
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) (K140092)Currie Medical Specialties, Inc.2014-04-16
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER (K140503)Boston Scientific2014-04-15
6200 / 6250 ULTRASOUND SYSTEM (K133905)Esaote, S.p.A.2014-04-15
COGENT MED-LIF (K132738)Cogent Spine, LLC2014-04-15
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR (K140831)Care Fusion2014-04-15
← Previous Next →

Track 2014 automatically

Every clearance here is in the API, with alerts when new ones post.