7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PROXIMATE (TMD) TISSUE MEASURING DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 18, 2012
ENDOPATH** ETS45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2010
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