7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BIO-OSS COLLAGEN
FDA 510(k)
FDA Class 2
·Dental
QUANTITATIVE BLOOD POOL SPECT (QBS)
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
SONICFILL COMPOSITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·May 3, 2013
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011
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