15 results · 31ms · 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.

REVOLUTIONFULL FACE MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0

FDA 510(k)
FDA Class 2 ·Orthopedic

LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PB560 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·August 22, 2011

PB560 VENTILATOR X1

FDA Adverse Event
Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011

SPINNING SPIROS® CLOSED MALE LUER, RED CAP

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025

HOLDING SLEEVE-STANDARD FOR MATRIX

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code LXH·April 29, 2013

GLOBAL ADVANTAGE STEM 12 MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWS·May 3, 2011

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 25, 2008

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

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