9 results · 22ms · Sources: EU EUDAMED, US FDA

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HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05

FDA 510(k)
FDA Class 2 ·Cardiovascular

WEINMANN SOMNOMASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

MONITORING SYSTEM, MODEL ARGUS PB-2200

FDA 510(k)
FDA Class 2 ·Cardiovascular

STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code HXX·August 14, 2015

AUTOPSY SAW 115V

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAB·April 29, 2013

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 10, 2011

SOFTCLIX PLUS LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 24, 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