7 results
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20ms
·
Sources: EU EUDAMED, US FDA
CO-OXIMETER CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGITRON IEC II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·January 8, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 18, 2010
HIRES 90K IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·February 24, 2014
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