9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ALIANS ULNA LOCKING PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707011248·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 2
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277101051·Cheng Medium Tissue Protector with Handle
3 SERIES PHOTOTHERAPY CABINET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GOLIFE NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
NAIL HANDLE T2 TIBIA
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·October 6, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 3, 2013
PROXIMATE** LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 28, 2011
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019