8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRO-CLEAN
FDA 510(k)Erisma® LP MIS
FDA 510(k)
FDA Class 2
·Orthopedic
MINISCREWS ANCHORING SYSTEM, M.A.S.
FDA 510(k)
FDA Class 2
·Dental
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·December 10, 2012
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·June 23, 2015
CR TIBIAL INSERT SZ 5, 9MM, SLOPE ++
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 17, 2023
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025