Atlas FDA

2018

3,062 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Digital Blood Pressure Monitor-Wrist Style (K171833)Shenzhen Combei Technology Co., Ltd.2018-01-10
Tempus Pro Patient Monitor (K173768)Remote Diagnostic Technologies , Ltd.2018-01-10
Electrodes with snap / Electrodes with pigtail (K171722)Shenzhen Konmed Technology Co., Ltd.2018-01-10
Epicardia Anywhere (K173170)Medicomp, Inc.2018-01-10
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE (K173563)Tz Medical, Inc.2018-01-10
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (K172929)Boston Scientific Corporation2018-01-10
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System (K171421)Silony Medical GmbH2018-01-10
Swiss LithoClast Trilogy (K173234)E.M.S Electro Medical Systems S.A2018-01-10
Ultra/Phonic Scanning Gel (K163026)Pharmaceutical Innovations, Inc.2018-01-09
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021)Supersonic Imagine2018-01-09
reVive Perioral (K172662)Led Technologies, Inc.2018-01-09
Theradome LH80 PRO (K171775)Theradome, Inc.2018-01-09
Xpert Carba-R (K173263)Cepheid2018-01-09
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ (K172212)Ctl Medical Corporation2018-01-09
Guided Growth Plate System Plus (K172183)Orthofix Srl2018-01-09
Everest Spinal System (K173508)K2m2018-01-09
16ch T/R Hand Wrist Coil (K173469)Quality Electrodynamics, LLC2018-01-09
Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (K172193)Alma Lasers, Inc.2018-01-09
ULab Systems Treatment Planning Software (K171295)Ulab Systems, Inc.2018-01-09
Ultra/Phonic Free Conductivity Gel (K163027)Pharmaceutical Innovations, Inc.2018-01-09
Other-Sonic Transmission Gel (K163023)Pharmaceutical Innovations, Inc.2018-01-08
Thermage CPT System and Accessories (K173759)Solta Medical2018-01-08
Ultra/Phonic Conductivity Gel (K163024)Pharmaceutical Innovations, Inc.2018-01-08
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein (K172942)Beta Healthcare Products Pvt., Ltd.2018-01-08
invendoscopy E210 System (K173085)Invendo Medical GmbH2018-01-08
cNeuro cMRI (K171328)Combinostics OY2018-01-08
Cervical Spinal Truss System (CSTS) Interbody Fusion Device (K173159)4Web, Inc.2018-01-08
PreOp (K172858)Epilog2018-01-08
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic (K173471)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-08
EVOS Small Fragment Upper Extremity Plates (K173293)Smith & Nephew, Inc.2018-01-08
ViewPoint 6 (K173456)Ge Medical Systems Ultrasound and Primary2018-01-05
STRONG Dental Handpieces (K171436)Saeshin Precision Co., Ltd.2018-01-05
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (K171518)Zhejiang Kindly Medical Devices Co., Ltd.2018-01-05
Roadrunner Extra Support Wire Guide (K171948)Cook Incorporated2018-01-05
AquaShield System CO2- Fujifilm (K173650)United States Endoscopy Group, Inc.2018-01-05
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) (K173252)Becton, Dickinson and Company2018-01-05
EnsoETM (K172029)Attune Medical2018-01-05
Sureclear aligners (K171860)Emergo Global Consulting, LLC2018-01-05
Electrodes with silver conductive (K171721)Shenzhen Konmed Technology Co., Ltd.2018-01-05
ToggleLoc System (K173278)Biomet, Inc.2018-01-05
Pulpdent (Activa) Pit and Fissure Sealant with MCP (K172169)Pulpdent Corporation2018-01-05
Hair Up (K172968)Y & J Bio Co., Ltd.2018-01-05
Spineology Navigation Instruments (K172518)Spineology, Inc.2018-01-05
EON Portable Reverse Osmosis Water Purification System (K171099)Cantel2018-01-05
ePatch (K171410)Braemar Manufacturing, LLC2018-01-04
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module (K171113)Lina Medical Aps2018-01-04
EarlySense Bed Sensing Unit (K171836)Earlysense, Ltd.2018-01-04
WAVE Clinical Platform (K171056)Excel Medical Electronics, LLC2018-01-04
BIO-C SEALER (K172701)Angelus Industria DE Produtos Odontologicos S/A2018-01-04
OmniCap (K171235)Respirion, Inc.2018-01-04
Attain Assist CS Access Catheter (K171819)Creganna Medical Also Doing Business AS Ceganna Tactx Medica2018-01-04
Bone Screws 6.5mm (K172456)Lima Corporate S.P.A.2018-01-04
Tec 820, Tec 850 (K172702)Datex-Ohmeda, Inc.2018-01-04
Alians Elbow Locking Plating System (K171372)Newclip Technics2018-01-04
Juliet Ti LL (K173702)Spineart2018-01-03
Facet Screw Fixation System (K173198)U&I Corporation2018-01-03
Straumann CARES Abutments CoCr (K172798)Institut Straumann AG2018-01-03
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (K172502)Biomet Manufacturing Corp2018-01-03
AirFit F20 (K170924)Resmed, Ltd.2018-01-03
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System (K172860)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-02
Snorer's Friend (K171529)Scope Healthcare Technologies Pty, Ltd.2018-01-02
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (K163712)Shenzhen Wisonic Medical Technology Co. , Ltd.2018-01-02
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Every clearance here is in the API, with alerts when new ones post.