8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
TRUGRAFT BGS SYRINGE, MODEL 600-041
FDA 510(k)
FDA Class 2
·General Hospital
K042172
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASR ACETABULAR IMPLANT 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 9, 2013
ADVANTAGE SERIES 26 OBS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 15, 2011
INSIGNIA PLUS
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012