17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONSTELLATION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052015831·Round Burr 6,5
M2a-Magnum™
FDA UDI
Biomet Orthopedics, LLC·00887868474286·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111287725·OP SCISS 6 1/2" STR SH/BL
MAGNUM INSTRUMENTATION
FDA UDI
Biomet Uk Ltd·05019279440276·
Portex
FDA UDI
ICU MEDICAL, INC.·15019315019371·
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·Neurology
PANALOK RC LOOP ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 22, 2024
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·June 3, 2013
INRATIO
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC.·Product code GJS·June 15, 2011
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·August 29, 2008
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
ARTEFILL DERMAL FILLER
FDA Adverse Event
Injury
·SUNEVA MEDICAL, INC.·Product code LMH·September 16, 2022
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021