10 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LATARJET CORTICAL SCREW SET

FDA 510(k)
FDA Class 2 ·Orthopedic

PHENCYCLIDINE

FDA 510(k)
FDA Unclassified ·Unknown

FASTPACK CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 18, 2025

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

DEXTRUS 4137

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013

DUROM US ACETABULAR COMPONENT 44/38 D

FDA Adverse Event
Other ·ZIMMER GMBH·Product code KWB·April 28, 2011

SYNERGY

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERAITONS CO, MED REL·Product code LGW·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