8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electrical Neuromuscular Stimulator, Cure Trio
FDA 510(k)
FDA Class 2
·Neurology
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUBTALAR PEG IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 18, 2008
UNKNOWN DEPUY PFC PLI SZ 5 8MM TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code JWH·September 2, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025