14 results
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27ms
·
Sources: EU EUDAMED, US FDA
HALA'TUS 1 OXYGENATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517963154·Brigade Lateral Trial, 11x38x28mm 10°
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746111327·DB BRACKET MINI MS MAND RIGHT CUSPID 5MM LANG 0...
AirLife™
FDA UDI
AIRLIFE·10889483587157·AirLife™ Isothermal™ Breathing Circuit Accessor...
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
GETINGE 400HC/500HC SERIES STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016
IT VITE XLPE LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OQG·March 9, 2018
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 30, 2014
VIRTUOSAPH PLUS, EVH
FDA Adverse Event
Injury
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·January 3, 2013
GORE TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·November 16, 2010
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·October 19, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016
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