Atlas FDA

2016

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

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RecordFirmDate
RejuvatoneMD (K152199)Trophy Skin, Inc.2016-03-23
VDT985US Vicks SmartTemp Thermometer (K152975)Kaz USA, Inc., A Helen of Troy Company2016-03-23
Straumann Bone Level Tapered Implants (K153758)Institut Straumann AG2016-03-23
cryoFORM cryoICE cryoablation probe (K152337)AtriCure, Inc.2016-03-22
Great Basin Shiga Toxin Direct Test (K152955)Great Basin Scientific, Inc.2016-03-22
Single Use Aspiration Needle NA-U401SX (K160098)Olympus Medical Systems Corp.2016-03-22
QbCheck (K143468)Qbtech AB2016-03-22
Ingenia 1.5T and Ingenia 1.5T S R5.2 (K153324)Philips Medical Systems Nederlands B.V.2016-03-22
Glide-On Vinyl Examination Gloves (K151754)Medline Industries, Inc.2016-03-22
Z-Span Plate System (K160362)Zavation, LLC2016-03-22
ClearMet (K152051)Mycone Dental Supply Co., T/A Keystone Industries2016-03-22
ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm (K160521)Ethicon Endo-Surgery, LLC2016-03-22
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (K160229)Cook Ireland, Ltd.2016-03-21
Powder Free Polychloroprene Examination Glove Green (K153510)Terang Nusa Sdn Bhd2016-03-21
OS2(R)-VP Varisation Staple (K153770)In2bones Sas2016-03-21
Genesis Low Temperature Reusable Rigid Container System (K153554)Carefusion 2200, Inc.2016-03-21
Venus Versa System (K153717)Venus Concept , Ltd.2016-03-21
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (K153019)Bio Protech, Inc.2016-03-21
Oniris (K150566)Sas Oniris2016-03-21
D-SPECT Processing and Reviewing Workstation (K160120)Spectrum Dynamics , Ltd.2016-03-21
SpeqT (K160420)Signostics Limited2016-03-21
SPINAUT-P (K150915)Imedicom Co., Ltd.2016-03-18
Quanta System Surgical Laser fibers (K160513)Quanta System Spa2016-03-18
NILE Alternative Fixation Spinal System (K160208)K2m, Inc.2016-03-18
AUDICOR CA300/CC100 Analyzer with SDB (K151433)Inovise Medical, Inc.2016-03-18
Tuxedo Digital Dental Sensor (K153710)Led Dental, Inc.2016-03-18
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) (K151749)Siemens Medical Solutions USA, Inc.2016-03-18
OVA1 Next Generation (K150588)Vermillion, Inc.2016-03-18
CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor (K151499)Caretaker Medical, LLC2016-03-18
FibroScan 530 Compact (K160524)Echosens2016-03-18
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (K153741)Hangzhou Clongene Biotech Co., Ltd.2016-03-18
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (K151845)CooperSurgical, Inc.2016-03-18
Optetrak Advanced Patella (K160484)Exactech, Inc.2016-03-18
DBB-06 Hemodialysis Delivery System (K152938)NIKKISO CO., LTD.2016-03-18
CorPath 200 System (K152999)Corindus, Inc.2016-03-18
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana (K153646)Safecare Biotech (Hangzhou) Co., Ltd.2016-03-18
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (K160454)AtriCure, Inc.2016-03-18
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K153693)Immunalysis Corporation2016-03-18
Slim UP ULTRA (K151722)Aime Medical, Inc.2016-03-18
MetaNeb 4 System (K151689)Hill-Rom Services Pte, Ltd.2016-03-17
NuVasive® TLX Interbody System (K153627)Nu Vasive, Incorporated2016-03-17
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color (K152707)Minghao Medical Products Co., Ltd.2016-03-17
Rezum System (K160417)Nxthera, Inc.2016-03-17
LiDCOunity Monitor (K152935)Lidco, Ltd.2016-03-17
Apollo System (K152699)Penumbra, Inc.2016-03-17
CONQUEST FN (K152686)Smith & Nephew2016-03-17
OVENT (K160234)Oventus Manufacturing Pty, Ltd.2016-03-17
ClearPoint System (K160434)Mri Interventions, Inc.2016-03-17
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color (K152705)Jiayuan Medical Products Co., Ltd.2016-03-17
Axeo 3 Patient Monitor (K153079)Axeo Medical Technologies, LLC2016-03-17
Specular Microscope CEM- 530 (K151706)Nidek Co., Ltd.2016-03-17
Sungshim Insulin Pen Needle (K152334)Sung Shim Medicare Co., Ltd.2016-03-17
Endo Keeper (K152598)Nelis2016-03-17
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch (K160462)Biofire Diagnostics, LLC2016-03-17
Giraffe OmniBed Carestation CS1 (K152814)Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company2016-03-17
Xeleris 4.0 Processing and Review Workstation (K153355)GE Healthcare2016-03-16
FUJIFILM FC1 Ultrasound System (K160406)FUJIFILM Sonosite, Inc.2016-03-16
HemosIL Silica Clotting Time (K160445)Instrumentation Laboratory CO2016-03-16
NobelZygoma 45° (K152093)Nobel Biocare AB2016-03-16
Cerafix Dura Substitute (K153613)Acera Surgical, Inc.2016-03-16
Vitrea CT Colon Analysis (K160150)Vital Images, Inc.2016-03-16
SUSTAIN Additional Implants (K151665)Globus Medical, Inc.2016-03-16
DReal (K153519)Carevature Medical, Ltd.2016-03-16
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (K153250)Renovis Surgical Technologies2016-03-16
SPINAUT-V, SPINAUT-S, SPINAUT-I (K151268)Imedicom Co., Ltd.2016-03-16
PerioLase Nd:YAG Pulsed Dental Laser System (K151763)Millennium Dental Technologies, Inc.2016-03-15
AlertWatch: OR (K153335)Alertwatch, LLC2016-03-15
Xspan Laminoplasty Fixation System (K160114)X-Spine Systems, Inc.2016-03-15
Dignity Dual Port (K153238)Medcomp ( Medical Components)2016-03-15
MODEL 621/624 BIOMAGNETOMETER (K151135)Tristan Technologies, Inc.2016-03-15
AOS Anterolateral Proximal Humeral Plate (K160409)Advanced Orthopaedic Solutions, Inc.2016-03-15
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (K160457)Biofire Diagnostics, LLC2016-03-15
NeoTract UroLift System UL500 (K153584)Neotract, Inc.2016-03-15
ArthrexVIP Web Portal (K153612)Custom Orthopaedic Solutions, Inc.2016-03-15
Endoform Reconstructive Template (K153633)Aroa Biosurgery Limited (Formerly Mesynthes Limited)2016-03-15
UCP Stem (K152530)United Orthopedic Corporation2016-03-14
Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, (K153119)Summit Industries, LLC2016-03-14
Cryotop US (K153027)Kitazato Biopharma Co., Ltd.2016-03-14
Sleep Profiler (K153412)Advanced Brain Monitoring, Inc.2016-03-14
Reprocessed Electrophysiology Catheter (K153153)Innovative Health, LLC2016-03-14
MicroMatrix (K153754)Acell, Inc.2016-03-14
Allied Biocompat Abutment for Nobel Replace Interface (K152845)Allied Dental Solutions2016-03-14
ImmunoCard STAT! HpSA (K153661)Meridian Bioscience, Inc.2016-03-14
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling (K153041)Integra LifeSciences Corporation2016-03-14
Full Automatic (NIBP) Blood Pressure Monitor (K160145)Health & Life Co., Ltd.2016-03-13
Surefire Infusion System (K160662)Surefire Medical, Inc.2016-03-11
StimQ Peripheral Nerve Stimulator (PNS) System (K152178)Stimq, LLC2016-03-11
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System (K160374)Tangent Medical Technologies, Inc.2016-03-11
ImmuLisa Enhanced Centromere Antibody ELISA (K151559)Immco Diagnostics, Inc.2016-03-11
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (K160064)Infobionic, Inc.2016-03-11
Rapicide PA High-Level Disinfectant Test Strips (K152394)Medivators, Inc.2016-03-11
NovaCross Microcatheter (K160389)Nitiloop , Ltd.2016-03-11
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (K151506)Salter Labs2016-03-11
Clean & More (K151748)3M Deutschland GmbH2016-03-11
SYLK PERSONAL LUBRICANT (K152646)Toro Management, LLC Dba Sylk2016-03-11
chromID MRSA (K151688)bioMerieux, Inc.2016-03-11
CAAS Workstation (K151780)Pie Medical Imaging BV2016-03-11
Dentti System (K151965)Martz, Inc.2016-03-11
BellaFuse (K151271)Hans Biomed Corp.2016-03-11
PEEK Customized Cranial Implant (K153248)Stryker2016-03-10
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