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

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MR-TOUCH OPTION

FDA 510(k)
FDA Class 2 ·Radiology

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEPUY C-STEM SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LINEAR? 3-4

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 10, 2025

SINAI HSP BALTIMORE MD 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

LAKELAND REG LAKELAND FL 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

WA ADVENT TAKOMA PARK MD 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

IOWA METH DES MOINES IA1

FDA Adverse Event
Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 10, 2011

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 29, 2013

GREENLIGHT LASER

FDA Adverse Event
Malfunction ·LASERSCOPE·Product code GEX·July 16, 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