14 results
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18ms
·
Sources: EU EUDAMED, US FDA
AIRCO NITROUS OXIDE REGULATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994617804·LID 1850106 SCREW CADDY LID
CoRoent
FDA UDI
Nuvasive, Inc.·00887517376640·CoRoent® Small Contoured, S6
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501060·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981123949·14x13x6mm, 7 Degree, No Profile Integrated Spacer
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515223400·Obwegeser Perio Elev, sharp, cvd, 11mm
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011850106000·Standard Band, Tooth 13/23, Size 6
NOVOFINE AUTOCOVER 30G X 8MM
FDA 510(k)
FDA Class 2
·General Hospital
2MP Color LCD Monitor, RadiForce RS240
FDA 510(k)
FDA Class 2
·Radiology
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 1, 2010
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·November 27, 2012
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021