8 results · 26ms · Sources: EU EUDAMED, US FDA

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THE CRITERION II PACING SYS. MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

REPLICATION MEDICAL VESSEL GUARD

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYMBIQ DUAL CHAN INF

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014

PROMUS ELEMENT ¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 24, 2012

ATTAIN OTW

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010

Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.

FDA Enforcement
Class II ·Terminated·Medical Positioning Inc·August 20, 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