8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AUDIOTECH MODEL DB
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Brigade
FDA UDI
Nuvasive, Inc.·00887517962911·Brigade Lateral Trial, 13x34x32mm 25°
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE SUCTION AND IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 30, 2014
DENTEK COMFORT-FIT DENTAL GUARD
FDA Adverse Event
Injury
·DENTEK ORAL CARE, INC.·Product code OBR·January 3, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 26, 2007
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