12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Anti-bacterial bandage
FDA 510(k)
FDA Unclassified
·Unknown
Mediflex 3.5mm Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102100475·Wave Grasper, w/ Flush Port & Locking Handle, 3...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102466·ANIS PHACO CHOPPER, LEFT
CRYOCARE CS SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BONDILOXS TOPICAL HEMOSTATIC DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 25, 2023
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·January 4, 2013
ALLERGAN NATRELLE
FDA Adverse Event
Injury
·ALLERGAN·Product code FTR·August 25, 2011
CONSENSUS KNEE SYSTEM
FDA Adverse Event
Malfunction
·CONSENSUS ORTHOPEDICS INC.·Product code JWH·July 30, 2014
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020