15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Z-Span Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...
Monza Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711603621·62mm Cervical Plate, 3 Level
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045126·Unitek(TM) Molar Band General Purpose Wide Regu...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....
CAMBRIDGE HEART OEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VANGUARD ASYMMETRICAL PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 20, 2024
VIRTUOSO DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 10, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 22, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021