13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIRES TUOHY NEEDLES 17GA. X 4 1/2
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994617750·LID 1850111 MAS 8.5 SCREW MODULE LID
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501110·
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776353711·Cervical Disk Marker, Single
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981123994·14x13x11mm, 7 Degree, No Profile Integrated Spacer
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011850111000·Standard Band, Tooth 13/23, Size 11
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·00889981123997·No Profile Spacer, 14x13x11mm, 7 Degree, Sterile
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
FDA 510(k)
FDA Class 2
·Cardiovascular
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
FDA 510(k)
FDA Class 2
·Anesthesiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
USERS MANUALS
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 29, 2012
OSTYCUT DISPOSABLE BONE BIOPSY NEEDLES
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code DWO·September 21, 2010
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