7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RPI ENTERAL FEEDING BAG 1000ML AND 500ML
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
FDA 510(k)
FDA Class 2
·Dental
CHARMCARE TABLETOP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
ASKU
FDA Adverse Event
Death
·MEDTRONIC MILACA INC.·Product code DTE·November 18, 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