9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QUICK CEPT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209131525·
GLOBAL SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VarseoSmile Crown plus
FDA 510(k)
FDA Class 2
·Dental
HEMOCUE GLUCOSE 201 SYSTEM
FDA Adverse Event
Malfunction
·HEMOCUE AB·Product code CGA·April 25, 2019
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 9, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·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