12 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.

PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

TITANIUM MIDDLE EAR PROSTHESES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450259924·

MULTI-STIM, MODEL MS-100

FDA 510(k)
FDA Class 2 ·Neurology

CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE

FDA 510(k)
FDA Class 2 ·Hematology

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·October 1, 2024

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·October 1, 2024

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·March 13, 2013

ADAPTER SLEEVE 11/13+0

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

IMPLANTIUM

FDA Adverse Event
Other ·DENTIUM CO., LTD.·Product code DZE·February 22, 2008

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

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024