20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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