10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221117113·3M™ Victory Series™ First Molar Bands, 953-464,...
SERVICE MANAGER SM40SE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FDR D-EVO flat Panel Detector System
FDA 510(k)
FDA Class 2
·Radiology
GOBED II MED/SURG
FDA Adverse Event
STRYKER CORP., MEDICAL DIV·Product code FNL·December 28, 2010
PROTECTA XT DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·February 9, 2013
PERFORATOR DRIVER W/HUDSON END
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·July 23, 2014
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024
1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015