Atlas FDA

2017

3,200 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Mako Partial Knee Application (K170584)Mako Surgical Corp.2017-05-11
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems (K170679)Medtronic Sofamor Danek2017-05-11
Anybattery C2 Rechargeable Battery (K160667)Anybattery, Inc.2017-05-11
ABCcolla Collagen Matrix (K162348)Acro Biomedical Co., Ltd.2017-05-10
Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (K170650)Orthofix Srl2017-05-10
MOJAVE Expandable Interbody System (K171097)K2m, Inc.2017-05-10
Lubricity (K163476)You First Services, Incorporated2017-05-10
ALP IFCC Gen.2 (K171080)Roche Diagnostics Operations (Rdo)2017-05-10
MALUC™ Total Hip Arthroplasty System (K162125)Surgtech, Inc.2017-05-10
I.B.S. osteosynthesis screws (K170594)In2bones Sas2017-05-10
EpiAccess System (K170831)Epiep, Inc.2017-05-09
Guider Catheter Introducer (K171081)Rhythm Xience, Inc. (Rxi)2017-05-09
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) (K170393)Zibo Chengxun Automatic Device Co., Ltd.2017-05-09
Ablation Confirmation (K171022)Neuwave Medical, Inc.2017-05-09
Oxitone 1000 (K163382)Oxitone Medical , Ltd.2017-05-09
Digital Blood Pressure Monitor-Automatic Upper Arm Style (K163606)Shenzhen Combei Technology Co., Ltd.2017-05-09
ExSpiron 1Xi (K162131)Respiratory Motion, Inc.2017-05-09
Alpha Pure (K163117)Koroad America2017-05-09
Ocata Anterior Cervical System (K170342)Kalitec Direct, LLC2017-05-09
Fujifilm Diathermic Slitter (FlushKnife) (K171096)Fujifilm Medical Systems U.S.A, Inc.2017-05-09
NxStage System One Plus (K170469)Nxstage Medical, Inc.2017-05-09
Craniomaxillofacial Distraction System (CMFD) (K162594)Synthes USA Products, LLC2017-05-08
Resultz Lice & Egg Removal Kit (K151562)Piedmont Pharmaceuticals, LLC2017-05-08
Venus Silk.expert (K170734)Cyden Limited2017-05-08
Thermi Reusable Non-invasive RF Electrode (K171094)Thermgen, L.L.C2017-05-08
Adhesive Electrodes (K170744)Reno Medical , Ltd.2017-05-08
Fingertip Pulse Oximeter (K161938)Xuzhou Yongkang Electronic Science Technology Co., Ltd.2017-05-08
CreoDent Solidex Customized Abutment (K162734)Creodent Prosthetics, Ltd.2017-05-08
Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 (K170111)Pulsaderm, LLC2017-05-08
Will3D (K170180)Hdx Will Corp.2017-05-08
VariAx 2 Foot System (K170771)Stryker GmbH2017-05-08
GORE VIABIL Short Wire Biliary Endoprosthesis (K170740)W. L. Gore & Associates, Inc.2017-05-08
Rampart One Lumbar Interbody Fusion Device (K163670)Spineology, Inc.2017-05-08
Ceribell Pocket EEG Device (K170363)Ceribell, Inc.2017-05-08
Precifit Medical Kirschner Wires (K163327)Precifit Medical, Ltd.2017-05-08
LENSAR Laser System - fs 3D (LLS-fs 3D) (K170576)Lensar, Inc.2017-05-05
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) (K170152)Hartalega Sdn Bhd2017-05-05
A08 Power wheelchair (K163204)Kunshan Aoshida Electric Technology Co., Ltd.2017-05-05
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System (K171082)Orthofix, Inc.2017-05-05
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE (K163370)Phadia AB2017-05-05
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) (K162449)AngioDynamics, Inc.2017-05-05
Colink™ Plating System (K163293)In2bones USA, LLC2017-05-05
Rusch Silicone Foley Catheter (K161770)Teleflexmedical, Inc.2017-05-05
Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor (K163672)Nanova Biomaterials, Inc.2017-05-05
Internal Distraction - Sterile (K163315)KLS Martin L.P.2017-05-05
Kent Camera (K163070)Kent Imaging, Inc.2017-05-05
Medical Video Endoscope System (K171076)Zhuhai Pusen Medical Technology Co., Ltd.2017-05-05
In Reach (K170789)Curvebeam, LLC2017-05-05
MATRx plus (K163665)Zephyr Sleep Technologies2017-05-05
MINISCAV (K160950)Sedation Systems, LLC2017-05-05
Softcure 96 (K170068)Wellray Medical Laser, Inc.2017-05-05
SICAGE™ System (K170475)Sicage, LLC2017-05-05
ARK Voriconazole II Assay Test System (DEN160033)Ark Diagnostics, Inc.2017-05-05
Flex Robotic System and Flex Colorectal Drive (K162330)Medrobotics Corporation2017-05-04
Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (K163615)Carefusion 2200, Inc.2017-05-04
Arthrex SwiveLock Anchors (K171141)Arthrex, Inc.2017-05-04
Eclipse Kiss Zirconia (K163238)Ams2017-05-04
Cedic Enteral ENFit Transition Connectors (K162254)Cedic S.R.L.2017-05-04
VIPER PRIME™ Screws with Fenestrations (K170543)Medos International SARL2017-05-04
Foundation 3D Interbody (K162496)Corelink, LLC2017-05-04
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (K163468)Cook Ireland, Ltd.2017-05-04
Restore Moisturizing Vaginal Lubricant (K162207)Good Clean Love2017-05-04
Nucleus Image Management System (K171130)Nucleushealth, LLC2017-05-04
A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor (K163683)A&D Company, Ltd.2017-05-03
Hee HR Mini (K170269)Oriental Inspiration Limited2017-05-03
QZA and RS Dental Implant Systems (K163640)Trinon Titanium GmbH2017-05-03
Iridex TruFocus LIO Premiere (K170718)Iridex Corporation2017-05-03
Silhouette Featherlift (K171005)Silhouette Lift, Inc.2017-05-03
HALF DOME Posterior Lumbar Interbody System (K163481)Astura Medical2017-05-03
The IQool System (K162523)Braincool AB2017-05-03
Optilite Rheumatoid Factor Kit (K162263)The Binding Site Group , Ltd.2017-05-03
C.T.M. Mobility Scooter (K162952)Chien TI Enterprise Co., Ltd.2017-05-03
KISSloc Suture System (K170440)Arthrosurface, Inc.2017-05-03
Surgi Max Ultra (K170107)Elliquence, LLC2017-05-03
PHAKOS Disposable Retinal Cryo Probe (K162756)Phakos2017-05-03
Asahi ViE-U Series Dialyzer (K162248)Asahi Kasei Medical Co., Ltd.2017-05-03
PrisMax Control Unit (K163530)Baxter Healthcare Corp2017-05-03
SURESHOT Distal Targeting System V4.0 Trauma Interface (K170977)Smith & Nephew, Inc.2017-05-03
Locking Plate System (K162380)Beijing Keyi Medical Device Technology Co., Ltd.2017-05-02
BD MAX Extended Enteric Bacterial Panel, BD MAX System (K170308)Becton, Dickinson and Company2017-05-02
Vitoss Bioactive (BA) Injectable (K163621)Orthovita, Inc.2017-05-02
AXIS Image Management System (K171098)Sonomed, Inc.2017-05-02
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (K170141)Stimwave Technologies Incorporated2017-05-02
Collagen Meniscus Implant XL (K170364)Ivy Sports Medicine, LLC2017-05-02
Airworks Nebulizer pe1200m (K162041)Convexity Scientific, LLC2017-05-02
AssureTech Panel Dip Test, AssureTech Quick Cup Test (K170049)Assure Tech. (Hangzhou) Co, Ltd.2017-05-02
iGlucose Blood Glucose Monitoring System (K161790)Bionime Corporation2017-05-02
Xultan 5.5 Pedicle Screw System (K170108)Met One Technologies2017-05-02
NAVIO (K170360)Blue Belt Technologies, Inc.2017-05-02
ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (K163626)Luminex Corporation2017-05-02
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (K160781)Semperit Investments Asia Pte , Ltd.2017-05-02
ScanX Intraoral View (K170733)Duerr Dental AG2017-05-01
NuVasive NuvaLine Mobile App (K162647)Nu Vasive, Incorporated2017-05-01
XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack (K170334)Revmedx, Inc.2017-05-01
StealthStation S8 Spine Software v1.0.0 (K170011)Medtronic Navigation2017-05-01
CAPTIVATE™ Compression Screws (K162825)Globus Medical, Inc.2017-05-01
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval (K170294)C. R. Bard2017-05-01
NuVasive CoRoent Ti-C System (K163707)Nu Vasive, Incorporated2017-05-01
Remel Spectra ESBL (K162620)Remel, Inc.2017-05-01
Bovie J-Plasma Precise FLEX Handpiece (K170777)Bovie Medical Corporation2017-05-01
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