15 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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InPen Dose Calculator
FDA 510(k)
FDA Class 2
·Anesthesiology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704512700·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025639·Oldberg Retr, 4 prong, 8 1/4"
DIOLASE 10S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RELIMESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·October 17, 2014
SURGISTOOL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FZM·June 21, 2013
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·July 8, 2011
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021
KIT BD MAX ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
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