7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BD GENEOHM MRSA ACP ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
RANDOX GLUCOSE (GOD/PAP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·May 6, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 16, 2014
SPRINTER LEGEND RX BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code LOX·April 19, 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