21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
FDA 510(k)
FDA Class 2
·Radiology
TITAN POROCOAT HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CD SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·SOFAMOR DANEK EUROPE·Product code KWP·May 19, 1999
INFUMED
FDA Adverse Event
Malfunction
·MCKINLEY MEDICAL,LLC·Product code FRN·October 27, 2005
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 21, 2018
NEXGEN MIS STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 28, 2013
CRE(TM) BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KOG·March 28, 2011
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MAF·April 21, 2008
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 20, 2018
SUMMIT POR TAPER SZ6 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 1, 2018
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 28, 2018
SMARTNAIL
FDA Adverse Event
Injury
·CONMED CORPORATION·Product code MAI·July 29, 2019
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 18, 2019
GORE DUALMESH PLUS BIOMATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·June 12, 2019
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. - 8010379·Product code LPH·July 1, 2015
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
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