34 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Harvard PremiumFill Dentine

FDA UDI
Harvard Dental International GmbH·EHAR70822061·Universal light cure nano-hybrid composite for ...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450180389·

ZAVATION

FDA UDI
Zavation LLC·00842166186705·8mm X 22mm 6° Trial

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

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

NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

FDA Adverse Event
Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

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

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2013

SMART CONTROL NITINOL STENT SYSTEM

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code FGE·May 9, 2011

ACCU-CHEK ULTRAFLEX INFUSION SET

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·July 25, 2008

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024