Atlas FDA

2016

2,956 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Cajun Commando 4x4 (K152672)Lil Critter, LLC2016-01-21
aap LOQTEQ VA Radius Set 2.5 (K153034)Aap Implantate AG2016-01-21
DeVilbiss DV6WM Wireless Modem (K152810)Devilbiss Healthcare, LLC2016-01-21
AQUACEL Ag Surgical SP Dressing (K152926)Convatec Limited2016-01-21
Biomet Spine Fusion System (K153695)Biomet Spine, LLC2016-01-21
Pruitt F3-S Polyurethane Carotid Shunt (K152833)LeMaitre Vascular, Inc.2016-01-21
Corin Metafix Hip Stem (K153381)Corin U.S.A. Limited2016-01-21
Release Laminoplasty Fixation System (K153735)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016-01-21
PleuraFlow System (K153681)Clearflow, Inc.2016-01-20
AirLife Infant Single Limb Heated Wire Circuit (K151959)Carefusion, Inc.2016-01-20
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System (K151558)Neurotherapies Reset GmbH2016-01-20
Stereo 3D option for Vision Applications (K152352)GE Medical Systems SCS2016-01-20
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives (K153643)Alcon Laboratories, Inc.2016-01-20
Pentacam AXL (K152311)Oculus Optikgerate GmbH2016-01-20
AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer (K151726)Stryker Corporation2016-01-20
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (K152463)Poriferous, LLC2016-01-20
Firefly Peritoneal Dialysis Connector Disinfection System (K151620)Puracath Medical, Inc.2016-01-20
CAS-One IR (K152473)Cascination AG2016-01-20
Stroke VCAR (K152584)GE Medical Systems SCS2016-01-20
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal (K153642)Alcon Laboratories, Inc.2016-01-20
Medtronic Transportation/Sterilization Cassettes (K152241)Medtronic Sofamor Danek USA, Inc.2016-01-20
Venus Versa System (K152790)Venus Concept , Ltd.2016-01-20
SonoSite Edge II Ultrasound System (K153626)FUJIFILM Sonosite, Inc.2016-01-20
basixTOUCH40 Inflation Syringe (K153672)Merit Medical Systems, Inc.2016-01-20
Lustre PRO Light System (K143713)Ambicare Health, Ltd.2016-01-19
Hospira Extension Sets (K151969)Icu Medical, Inc.2016-01-19
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR (K152215)Dentalplus GmbH2016-01-19
MultiFIX S Ultra Knotless Fixation System (K153669)Arthocare Corporation2016-01-19
Flo Trac sensor, Volume View sensor (K152980)Edwards Lifesciences, LLC2016-01-19
Epic Extremity Cannulated Screw System (K153333)Epic Extremity, LLC2016-01-19
Unison-C Anterior Cervical Fixation System (K152793)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2016-01-19
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device (K153373)Medtronic Sofamor Danek2016-01-19
M.U.S.T. Pedicle Screw System (K153664)Medacta International2016-01-19
Phadia Prime (K151029)Phadia AB2016-01-19
True Flow Valvuloplasty Perfusion Catheter (K152613)C.R. Bard, Inc.2016-01-19
Capillus202 (K153618)Capillus, LLC2016-01-19
InstaClear Lens Cleaner (K152531)Gyrus Acmi, Inc.2016-01-15
Spine Wave Gen II Expandable Interbody System (K152620)Spine Wave, Inc.2016-01-15
da Vinci Xi Surgical System (K151794)Intuitive Surgical, Inc.2016-01-15
Medtronic Bio-Medicus Adult Cannula Kit (K153598)Medtronic, Inc.2016-01-15
BR-ABVS Viewer 1.0 (K151075)Taihao Medical, Inc.2016-01-15
Paragon T2 Wand with Integrated Cable (K153675)ArthroCare Corporation2016-01-15
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml (K151320)Becton, Dickinson and Company2016-01-15
HEALTHMYNE (K153289)Healthmyne, Inc.2016-01-15
Renovo Life Hard Carbon Coated Drill Bit (K151661)Renovo Life, LLC2016-01-15
INFX-8000C, V6.20 (K152697)Toshibamedical Systems Corporation2016-01-15
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System (K151848)Zimmer, Inc.2016-01-15
ECG Mini System Continuous ECG Monitor and Arrhythmia Detector (K151269)Lifewatch Technologies , Ltd.2016-01-15
PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) (K152669)Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std2016-01-15
Bovie Disposable Bipolar Ablator (K152777)Bovie Medical Corporation2016-01-15
Esophageal Cooling Device (K152450)Advanced Cooling Therapy, LLC2016-01-15
Reprocessed Vessel Sealer (K152134)Sterilmed, Inc.2016-01-15
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (K152522)Ecolab, Inc.2016-01-15
DISPOSABLE THERMOMETER PROBE SHEATHS (K152690)Pinghu Sama Medical Packing Co., Ltd.2016-01-15
Falck Medical Multifunction Tonometer, FAT1 (K151491)Falck Medical, Inc.2016-01-15
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm (K151228)Emerson & Co. Srl2016-01-15
MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge (K151081)Cardica, Inc.2016-01-15
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V (K143153)Olympus Medical Systems Corp.2016-01-15
VIVACE Electrosurgical System (K150409)Sung Hwan E&B Co.,Ltd2016-01-15
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System (K152361)Liebel-Flarsheim Company, LLC2016-01-14
ATLANTIS Abutment for NobelActive 3.0 (K151039)Dentsply International, Inc.2016-01-14
Spine Innovation Interbody System (K153356)Spine Innovation, LLC2016-01-14
FORZA PTC Spacer System (K152475)Orthofix, Inc.2016-01-14
GluStitch Twist Tissue Adhesive (K150032)Glustitch, Inc.2016-01-14
Rainbow Shine (K151842)Genoss2016-01-14
ebb Complete Tamponade System (K153591)Clinical Innovations, LLC2016-01-14
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method (K151487)Diatron U.S., Inc.2016-01-14
Turbett Surgical Container (K153025)Turbett Surgical, LLC2016-01-14
Cronus HP - High Pressure Peripheral Balloon Catheter (K151141)Nipro Medical Corporation2016-01-14
Amendia Stand-Alone Cervical System (K152972)Amendia, Inc.2016-01-14
Rainbow LS Pressing (K151846)Genoss2016-01-14
ARIX Wrist System (K151468)Jeil Medical Corporation2016-01-14
Tiger Cannulated Screw System (K153338)Trilliant Surgical, Ltd.2016-01-14
PillCam COLON 2 Capsule Endoscopy System (K153466)Given Imaging , Ltd.2016-01-14
LipiView II Ocular Surface Interferometer (K152869)Tearscience, Inc.2016-01-14
Aequalis Fx2 (K152966)Tornier S.A.S.2016-01-14
Spectra Optia Apheresis System (K153601)Terumobct, Inc.2016-01-14
SALVATION(R) External Fixation System (K153635)Wrightmedicaltechnologyinc2016-01-13
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K152541)Penumbra, Inc.2016-01-13
NuVasiveNVM5 System (K152942)Nu Vasive, Incorporated2016-01-13
BioHorizons CAD/CAM Abutments (K151621)BioHorizons Implant Systems, Inc.2016-01-13
S50 Digital Color Doppler Ultrasound System (K152854)Sonoscape Medical Corp.2016-01-13
FFRct (K152733)HeartFlow, Inc.2016-01-13
IFS Fixation Scaffold System (K152627)Metric Medical Devices, Inc.2016-01-13
Frontier Medical Devices In-Line Orthopedic Cable Cerclage System (K153242)Frontier Medical Devices, Inc.2016-01-13
LL TENS 160A, LL TENS 160B (K152374)Fuji Dynamics , Ltd.2016-01-13
VerteLP Interbody Fusion Device (K151312)Vgi, LLC2016-01-13
TheraVision Ultrasound Ablation System and ACOUSTx Applicators (K150019)Acoustic Medsystems, Inc.2016-01-13
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K151725)Advanced Sterilization Products2016-01-13
Sonishield 100 Antimicrobial Ultrasound Gel (K151070)Quotient Medical2016-01-13
Nerve Capping Device (K152684)Polyganics Innovations BV2016-01-13
IntraNovo Microcatheter (K153125)Texasmedical Technologies, Inc.2016-01-13
Reprocessed Stryker External Fixation Devices (K153415)Stryker Sustainability Solutions2016-01-13
CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) (K152509)Altatec GmbH2016-01-12
Cios Connect (K153147)Siemens Medical Solutions USA, Inc.2016-01-12
core nova Complete Operating Room Endoscopy (K151282)Richard Wolf Medical Instruments Corp.2016-01-12
3MP Color LCD Monitor, RadiForce RX350 (K153354)Eizo Corporation2016-01-12
Sofia Influenza A+B FIA (K153012)Quidel Corporation2016-01-12
IQSense Flow Sensor Mouthpiece (K150515)Sdi Diagnostics, Inc.2016-01-12
Biograph Horizon PET/CT (K152880)Siemens Medical Solutions USA, Inc.2016-01-12
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Every clearance here is in the API, with alerts when new ones post.