Atlas FDA

2015

3,020 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw (K143165)Zimmer, Inc.2015-03-31
HeatLux Pro I (K150175)Home Skinovations , Ltd.2015-03-31
Phasix Mesh (K142818)C. R. Bard2015-03-31
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES (K141785)Bsd Medical Corp.2015-03-31
ALERE I STREP A (K141757)Alere Scarborough, Inc.2015-03-31
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP (K141991)Olympus Medical Systems Copr.2015-03-31
Coalition AGX Plate and Coalition AGX Spacer (K142218)Globus Medical, Inc.2015-03-31
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) (K143567)Marvao Medical Devices, Ltd.2015-03-31
Eminent Foot Plate System (K143365)Eminent Spine2015-03-30
GORE SEAMGUARD Reinforcement (K150551)W. L. Gore & Associates, Inc.2015-03-30
Biomet Proximal Humerus Plating System (K143697)Biomet Manufacturing2015-03-30
IDS-iSYS CTX-I Calibration Verifiers (K143324)Immunodiagnostic Systems , Ltd.2015-03-30
CENTRAL MONITORING SYSTEM (K143695)Edan Instruments, Inc.2015-03-30
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM (K141527)Synthes USA2015-03-30
Ebony PTA 0.035 Peripheral Dilatation Catheter (K143036)Natec Medical , Ltd.2015-03-30
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System (K150529)C.R. Bard, Inc.2015-03-30
Scenium (K150192)Siemens Medical Solutions USA, Inc.2015-03-29
eMotion Faros ECG Mobile (K143032)Mega Electronics , Ltd.2015-03-29
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (K141385)Depuy Synthes Companies of Johnson & Johnson2015-03-27
F3 (K143180)Permobil AB2015-03-27
TYRX Neuro Absorbable Antibacterial Envelope (K150291)Medtronic Tyrx, Inc.2015-03-27
samaritan PAD 450P (K142709)Heartsine Technologies, Inc.2015-03-27
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET (K140110)Teleflex, Inc.2015-03-27
SOFIA 6F Catheter (K150366)MicroVention, Inc.2015-03-27
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter (K143609)Olympus Surgical Technologies America2015-03-27
Voyant Open Sealer-Divider Device (K143517)Applied Medical Resources2015-03-27
NuVasive NVM5 System (K143641)Nu Vasive, Incorporated2015-03-27
EBI External Implant System (K142426)Ebi, Inc.2015-03-27
MALDI Biotyper CA System (K142677)Bruker Daltonics, Inc.2015-03-27
WestTec Procedure Facemask;WestTec Surgical Facemask (K141085)Westtec, LLC2015-03-27
1717SGN / 1717SCN Digital Flat Panel X-ray Detector (K150150)Rayence Co., Ltd.2015-03-27
HealthGuard-15 (K143108)Futrex, Inc.2015-03-27
Patient Positioning Devices (K142420)Macromedics BV2015-03-27
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER (K141322)Cook Incorporated2015-03-27
GENADYNE SPIRO FOAM DRESSING KIT (K141961)Genadyne Biotechnologies, Inc.2015-03-26
Mammo Workstation (K143361)GE Healthcare2015-03-26
DD cubeX2 (K150196)Dental Direkt GmbH2015-03-26
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System (K150052)Nipro Diagnostics, Inc.2015-03-26
ER36 Series OAE Test System (K150491)Etymotic Research, Inc.2015-03-26
AVERT Contrast Modulation System (K150485)Osprey Medical, Inc.2015-03-26
FlexiMarc Marker (K142294)Cortex Manufacturing, Inc.2015-03-26
AVANCE FOAM DRESSING KITS (K141847)Molnlycke Health Care Us, LLC2015-03-26
Headway 27 Microcatheter (K142449)MicroVention, Inc.2015-03-26
PLIASURE Polyglycolide Synthetic Absorbable Suture (K142822)ETHICON, Inc.2015-03-26
A35 Diagnostic Ultrasound System (K150478)Samsung Medison Co., Ltd.2015-03-26
SOMATOM Definition AS Open (VA48) (K143409)Siemens Medical Solutions USA, Inc.2015-03-26
Nellcor Bedside SpO2 Patient Monitoring System (K142865)Covidien, LLC2015-03-26
GLOVE PORT (K141715)Nelis2015-03-25
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION (K141833)Medtronic Navigation, Inc.2015-03-25
Echo Bi-Metric Microplasty Line Extension (K150503)Biomet, Inc.2015-03-25
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface (K143073)Medtronic, Inc.2015-03-25
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (K143104)Kettenbach GmbH & Co. KG2015-03-25
ebb Complete Tamponade System (K150573)Clinical Innovations, LLC2015-03-25
VEGA Knee System, Columbus Total Knee System (K143443)Aesculap Implants Systems, LLC2015-03-25
F5 (K143014)Permobil AB2015-03-25
Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles (K143473)Cayenne Medical, Inc.2015-03-25
Modified ONFLEX Mesh (K142706)C.R. Bard, Inc.2015-03-25
Bio-Medicus Pediatric Cannula and Introducers (K143083)Medtronic, Inc.2015-03-25
Powder-free Clear Vinyl Patient Examination Gloves (K142892)Shenyi (Shandong) Plastic Products Co., Ltd.2015-03-25
PASS LP Spinal System (K142798)Medicrea International SA2015-03-25
INVISION TOTAL ANKLE REVISION SYSTEM (K142117)Wrightmedicaltechnologyinc2015-03-25
Baha 5 Sound Processor (K142907)Cochlear Americas2015-03-25
DISPOSABLE ENDOSCOPIC CANNULA (K140213)Dongguan Microview Medical Technology Co., Ltd.2015-03-25
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE (K143533)Prosidyan, Inc.2015-03-25
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K141278)Ellipse Technologies, Inc.2015-03-24
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA (K143096)Smith & Nephew, Inc.2015-03-24
Fluidshield* Surgical Mask with Expanded Chamber (K143287)Halyard Health, Inc.2015-03-24
MiniStim MS-IVB Peripheral Nerve Stimulator (K143095)Halyard Health, Inc.2015-03-24
Progressive Orthopedic Total Knee System (K142649)The Progressive Orthopaedic Company, LLC2015-03-24
Customer Remote Console (CRC) (K150193)Ge Medical Systems, LLC2015-03-24
Tarsa-Link Wedge Fixation System (K150368)Life Spine2015-03-24
VARIANT II TURBO HbA1c Kit - 2.0 (K142448)Bio-Rad Laboratories, Inc.2015-03-24
IBS IMPLANT SYSTEM (K140806)Innobiosurg Co., Ltd.2015-03-23
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING (K140954)Huizhou Foryou Medical Devices Co., Ltd.2015-03-23
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES (K140477)Molnlycke Health Care Us, LLC2015-03-23
Stryker CMF MEDPOR Customized Implant (K143173)Stryker2015-03-23
BigEasy Non-Rebreathing Valve (K142402)12th Man Technologies, Inc.2015-03-23
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) (K150099)Synthes (USA) Products, LLC2015-03-23
Revitive IX (OTC) (K143207)Actegy , Ltd.2015-03-23
Flow-Screw (K142776)Flow-Fx, LLC2015-03-23
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) (K141938)Terumobct, Inc.2015-03-23
Integra Laminoplasty System (K150469)Seaspine, Inc.2015-03-23
BioniCare Hand System (K142236)Vision Quest Industries, Inc.2015-03-23
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System (K143626)Zimmer Spine, Inc.2015-03-20
F1-Modular Pedicle Screw System (K142531)Degen Medical2015-03-20
EOPA 3D Arterial Cannula (K150422)Medtronic, Inc.2015-03-20
Volcano iFR Modality, iFR Scout feature (K150441)Volcano Corporation2015-03-20
BT-400 (K142332)Bio-Med USA2015-03-20
LM-9300 ELMA Lithotripter (K142561)Lite-Med, Inc.2015-03-20
ARROW Reverse Shoulder long keel and short keel glenoid base (K142778)Fournitures Hospitalieres Industrie2015-03-20
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System (K142344)Izi Medical Products, LLC2015-03-20
SUMMED HIGH PRESSURE LINE (K140356)Sunny Medical Device (Shenzhen) Co., Ltd.2015-03-20
SonoFlow Sonohysterography and Sonohysterosalpingography Device (K142545)Crossbay Medical, Inc.2015-03-20
PROLONG (DEN130047)Ergon Medical , Ltd.2015-03-20
Xenco Medical Lumbar Interbody System (K143158)Xenco Medical, LLC2015-03-20
Navio (K143668)Blue Belt Technologies, Inc.2015-03-20
NxStage Therapeutic Plasma Exchange (TPE) Cartridge (K143313)Nxstage Medical, Inc.2015-03-20
mDIXON XD (K143128)Philips Medical Systems Nederlands B.V.2015-03-20
BIOMATE DENTAL IMPLANT SYSTEM (K142174)Biomate Medical Devices Technology Co., Ltd.2015-03-20
Vyntus Walk (K142959)Carefusion Germany 234 GmbH2015-03-20
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Every clearance here is in the API, with alerts when new ones post.