8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPHTHALMIC SPONGES
FDA 510(k)
FDA Class 2
·Ophthalmic
BETA-TCP GRANULES
FDA 510(k)
FDA Class 2
·Orthopedic
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
FDA 510(k)
FDA Class 2
·Neurology
START-X TIP EMS INSERT 3
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·February 12, 2026
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 10, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 17, 2013
DLT TS CER HD 12/14 32MM +1
FDA Adverse Event
Injury
·DEPUY (IRELAND) 9616671·Product code LZO·July 8, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021