8 results · 21ms · Sources: EU EUDAMED, US FDA

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MODFICATION TO: EXPEDIUM SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500

FDA 510(k)
FDA Class 2 ·Cardiovascular

PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING

FDA 510(k)
FDA Class 2 ·Radiology

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 29, 2013

UNKNOWN ZIMMER KNEE IMPLANT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·May 3, 2011

I-STAT CTNI CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·July 28, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 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