9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AAP APS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Australis ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127756·
DIMENSION HAIC ASSAY, MODEL DF105
FDA 510(k)
FDA Class 2
·Hematology
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·January 23, 2007
STOCKERT 70 RF GENERATOR
FDA Adverse Event
Injury
·STOCKERT GMBH·Product code DRF·April 22, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code MIH·April 25, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·July 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