13 results · 27ms · Sources: EU EUDAMED, US FDA

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FLOWMEDICA BENEPHIT INFUSION SYSTEMS

FDA 510(k)
FDA Class 2 ·Cardiovascular

MICROSTREAM EXTERNAL BATTERY CHARGER

FDA 510(k)
FDA Class 2 ·Anesthesiology

POLYTITER SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2013

STARFISH 2 HEART POSITIONER

FDA Adverse Event
Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DWS·July 23, 2008

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 9, 2011

FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020

FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 17, 2018

FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 22, 2020

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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