23 results · 23ms · Sources: EU EUDAMED, US FDA

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3I OSSEOTITE DENTAL IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 15MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·December 4, 2023

N/A

FDA UDI
GEORGE TIEMANN & CO.·B58210514610·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

HairCheck-DT (Amphetamines)

FDA UDI
Quest Diagnostics·00868586000230·HairCheck-DT (Amphetamines) is an ELISA test ki...

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

FDA 510(k)
FDA Class 2 ·General Hospital

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·December 22, 2009

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 2, 2018

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·June 13, 2018

LYNX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 10, 2013

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·May 21, 2008

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 31, 2018

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 28, 2018

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 2, 2014

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017

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

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022