Atlas FDA

2014

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

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RecordFirmDate
NeumoFilt Ergo/Neumo Filt BiteOn (K142303)Medical Respiratory Devices S.L.2014-11-20
Xario 200, V3.0 (K143027)Toshibamedical Systems Corporation2014-11-20
Gel-Block 10X embolization pledgets (K143038)Vascular Solutions, Inc.2014-11-20
PhaLinx Hammertoe System (K142585)Wrightmedicaltechnologyinc2014-11-20
Audit MicroControls Linearity LQ Special Diabetes (K142978)Aalto Scientific, Ltd.2014-11-20
MaxZero Administration Sets (K143234)Care Fusion2014-11-20
COROENT SYSTEM (K141896)Nu Vasive, Incorporated2014-11-20
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS (K142012)Corpak Medsystems2014-11-20
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) (K140569)Maquet Cardiopulmonary, AG2014-11-19
FM-3000 FETAL MONITOR (K141194)Advanced Instrumentations, Inc.2014-11-19
VIAL-MATE Adaptor (K142600)Baxter Healthcare Corporation2014-11-19
ENDO-MARYLAND DISSECTOR (K141794)Ovesco Endoscopy AG2014-11-19
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device (K133303)Bio-Analysis, Inc.2014-11-19
MORTARA MONITORING WAVEFORM VIEWER (K141811)Mortara Instrument, Inc.2014-11-19
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE (K141640)Shantou Wealy Medical Instrument Co.,Ltd2014-11-19
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS (K141263)Biomet Manufacturing Corp2014-11-19
CENTERCROSS CATHETER (K140910)Roxwood Medical, Inc.2014-11-19
DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (K142399)Catheter Connections, Inc.2014-11-19
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL (K141977)Siemens Medical Solutions USA, Inc.2014-11-19
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K141755)Sejoy Electronics & Instruments Co., Ltd.2014-11-19
ECVUE MAPPING SYSTEM (K140497)Cardioinsight Technologies, Inc.2014-11-19
Xario 100, V3.0 (K143046)Toshibamedical Systems Corporation2014-11-19
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens (K142510)Synergeyes, Inc.2014-11-19
EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable (K142999)ArthroCare Corporation2014-11-19
ZOLL X SERIES (K141774)ZOLL Medical Corporation2014-11-19
VARIA-NCI (K141462)Neurochaos Solutions, Inc.2014-11-19
AVS AS PEEK Spacer (K142251)Stryker Corporation2014-11-19
Arthrex iBalance Patella Implant, Dome (K143047)Arthrex, Inc.2014-11-19
EXPEDIUM VERSE SPINE SYSTEM (K142185)Depuy Spine, Inc.2014-11-19
Reline System (K142499)Nu Vasive, Incorporated2014-11-19
Vertical Expandable Prosthetic Titanium Rib (K142587)Depuy Synthes Spine, Inc.2014-11-18
TRANSOM ANTERIOR CERVICAL PLATE (K142060)Neurostructures, Inc.2014-11-18
LessRay with Tracking (K142243)Saferay Spine, LLC2014-11-18
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (K140085)Cook Incorporated2014-11-18
RESCAN 700, CALLISTO EYE (K141844)Carl Zeiss Meditec, AG2014-11-18
J-SCREW COMPRESSION SCREW (K130019)Competitive Engineering, Inc.2014-11-18
3MP Color LCD monitor, RadiForce RS340 (K143098)Eizo Corporation2014-11-18
Bio-Medicus Adult Cannulae and Introducer (K142673)Medtronic, Inc.2014-11-18
UNEXEF-38G ULTRASOUND SYSTEM (K131973)Toyota Tsusho Corporation2014-11-18
AEQUALIS FX2 (K141345)Tornier S.A.S.2014-11-18
ERB ENDORECTAL BALLOON (K141958)Edge Medical, LLC2014-11-18
TRACTION POLYPECTOMY SNARE (K140923)Ovesco Endoscopy AG2014-11-18
INTERMITTENT PNEUMATIC COMPRESSION DEVICE (K141390)Wuhan Landing Medical Hi-Tech, Ltd.2014-11-18
Amedica Valeo II Interbody Fusion Device (K142347)Amedica Corp.2014-11-18
Sentinella 102; Sentinella 102 Horus (K143156)General Equipment For Medical Imaging (Oncovision-2014-11-18
BrainScope Ahead 100 (DEN140025)Brainscope Company, Inc.2014-11-17
ZIP MIS INTERSPINOUS FUSION SYSTEM (K141317)Aurora Spine, Inc.2014-11-17
SAIPH KNEE SYSTEM (K140222)Matortho2014-11-17
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM (K140595)Avantis Medical Systems, Inc.2014-11-17
PREMIER ETCH (K141839)Premier Dental Products Co.2014-11-17
ASCEND ELECTRODE (K140586)Neurometrix, Inc.2014-11-17
A-LINK Z (K133827)Osteo Vasive, LLC2014-11-17
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT (K140717)Siemens Healthcare Diagnostics2014-11-17
CUTANEOUS ELECTRODES (K142099)Bio Protech, Inc.2014-11-17
Speed, Speed Shift, Speed Titan, Speed Arc (K142292)Biomedical Enterprises, Inc.2014-11-17
SURGICAL GOWN (K141606)Cobes Industries Co., Ltd.2014-11-17
BULK FILL FLOWABLE COMPOSITE (K141994)Novocol, Inc.2014-11-14
V20 SYSTEM (K142093)Viora , Ltd.2014-11-14
Restoration Anatomic Shell (K142462)Stryker Orthopaedics2014-11-14
HEPARIN LOCK / FLUSH SYRINGES (K133446)Excelsior Medical Corporation2014-11-14
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh (K142908)Sofradim Production2014-11-14
JOURNEY II XR KNEE SYSTEM (K141471)Smith & Nephew, Inc.2014-11-14
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM (K142161)Conformis, Inc.2014-11-14
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K141617)Rex Medical, L.P.2014-11-14
RESPIRONICS REUSABLE HEATED TUBING (K140424)Respironics, Inc.2014-11-14
CL DETECT RAPID TEST (K141341)InBios International, Inc.2014-11-14
WEARABLE THERAPY GARMENTS (K141342)Axiobionics, LLC2014-11-14
Panorama Patient Monitoring Network (K142601)Shenzhen Mindray Bio-Medical Electronics Co.2014-11-14
GARMENT ELECTRODES (K141076)Shenzhen Dongdixin Technology Co., Ltd.2014-11-14
NUVASIVE NVM5 SYSTEM (K141968)Nuvasive, Inc.2014-11-14
TITAN Modular Total Shoulder System (K142413)Ascension Orthopedics2014-11-14
MINOP Disposable Introducer 26F (K142315)Aesculap, Inc.2014-11-14
TECOTHERM NEO (T NEO) (K140078)Inspiration Healthcare, Ltd.2014-11-14
MICRO GUIDE CATHETER ELITE (K140438)Cordis Corp., A Johnson & Johnson Co.2014-11-14
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter (K142565)Stryker Neurovascular2014-11-14
WEGO-PGCL Absorbable Surgical Monofilament Suture (K142810)Foosin Medical Supplies Inc., Ltd.2014-11-14
OTC COMBO TENS/EMS SYSTEM (K141299)Well-Life Healthcare Limited2014-11-14
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 (K140466)St. Jude Medical Systems AB2014-11-13
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH (K141593)Unimicro Medical Systems (Shenzhen) Co., Ltd.2014-11-13
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE (K140492)Marvao Medical Devices, Ltd.2014-11-13
DRAEGER JAUNDICE METER JM-105 (K133175)Draeger Medical Systems, Inc.2014-11-13
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT (K142115)Prismatik Dentalcraft, Inc.2014-11-13
OMNIPOD INSULIN MANAGEMENT SYSTEM (K140439)Insulet Corporation2014-11-13
REJUVALITE MD (K133896)Trophy Skin, Inc.2014-11-13
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector (K142254)St Jude Medical2014-11-13
ONE Snare Endovascular Microsnare System (K142265)Merit Medical Systems, Inc.2014-11-13
Biomet Headless Compression and Twist-off Screws (K142658)Biomet Manufacturing Corp2014-11-13
Shock Pulse-SE Lithotripsy System CYBERWAND II (K142428)Cybersonics, Inc.2014-11-13
VERAPLUG (K140352)Krishna Imports Inc Dba Stephens Instruments2014-11-13
AERO-LL LUMBAR CAGE SYSTEM (K142066)Stryker Corporation2014-11-13
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM (K141989)Mako Surgical Corporation2014-11-13
SYNGO, CT LIVER ANALYSIS (K133643)Siemens Medi Cal Solutions, Inc.2014-11-13
INTERNAL HYDRATING GEL (K141718)Combe Incorporated2014-11-13
ABL90 FLEX (K132691)Radiometer Medical Aps2014-11-13
GammaBeam 100 (K142219)Best Theratronics Limited2014-11-13
Barricade Embolization Coil System (K142513)Blockade Medical2014-11-13
ANT MODEL 1 (K141038)Advanced Nuclide Technologies, LLC2014-11-12
HIOSSEN IMPLANT SYSTEM (K140934)Hiossen, Inc.2014-11-12
COMPOSITE ORTHODONTIC BRACKETS (K140807)Ortho Specialties2014-11-12
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath (K142301)Cook Vascular, Inc.2014-11-12
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Every clearance here is in the API, with alerts when new ones post.