21 results · 23ms · Sources: EU EUDAMED, US FDA

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HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS

FDA 510(k)
FDA Class 2 ·Anesthesiology

Harvard MTA XR Fast OptiCaps

FDA UDI
Harvard Dental International GmbH·EHAR70815061·Endodontic repair cement, extra radiopacity, ex...

LEONE SPA

FDA UDI
LEONE SPA·08033707065777·INTRAORAL ELASTICS 6,5 oz 1/8" brown

OMNILINK .035 BILIARY STENT SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

SYMBIA T-SERIES

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013

E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

FDA Adverse Event
Injury ·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012

E.CAM, SYMBIA E

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012

E.CAM, SYMBIA E

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013

E.COM, SYMBIA E

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012

E.CAM

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·April 29, 2013

ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·April 26, 2011

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·July 23, 2008

GORE® TAG® THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 13, 2015

E.CAM, SYMBIA E

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC·Product code NIQ·June 10, 2005

TIT0001-003, Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons

FDA Recall
Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015