20 results · 24ms · Sources: EU EUDAMED, US FDA

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CORONIS 3MP

FDA 510(k)
FDA Class 2 ·Radiology

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046284681·Rotary diamond instrument for dental application

OCS-B

FDA 510(k)
FDA Class 2 ·Dental

SPIRALE DRUG DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIM400 IMPLANT MAGNET

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 19, 2017

COCHLEAR BAHA ATTACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 26, 2016

COOK® CERVICAL RIPENING BALLOON

FDA Adverse Event
Malfunction ·COOK INC·Product code PFJ·July 18, 2016

ATTRACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 15, 2015

COCHLEAR BAHA ATTACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016

BIM400 IMPLANT MAGNET

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016

SP MAGNET 3

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 13, 2016

COCHLEAR BAHA ATTRACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 14, 2016

BIM400 IMPLANT MAGNET

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 8, 2025

COOK® CERVICAL RIPENING BALLOON

FDA Adverse Event
Malfunction ·COOK INC·Product code PFJ·July 19, 2016

FORTE GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·October 1, 2014

HUDSON SHERIDAN/CF TRACHEAL TUBE

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code BTR·May 23, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWS·June 16, 2011

COCHLEAR BAHA ATTACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 10, 2016

ELECSYS TSH ASSAY

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015