8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINISITE*BIPOLAR FORCEPS** DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DYNAMETER 50 LB.
FDA 510(k)
FDA Class 1
·Orthopedic
STALIF (TM) C
FDA 510(k)
FDA Class 2
·Orthopedic
2520274-2013-10381
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·February 15, 2013
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·January 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 31, 2014
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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