10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENTROS CHRONIC HEMODIALYSIS CATHETER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERILMED REPROCESSED COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
CN ACQUISITION STATION
FDA 510(k)
FDA Class 2
·Radiology
CORAIL2 STD SIZE 12
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 3, 2013
MOUNTAINEER MINIPOLYAXIAL SCREWDRIVER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code HXX·September 16, 2014
EXTENSION, 60CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2011
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025