11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MUTARS Proximal Femur Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Anesthesiology
GIRAFFE INCUBATOR
FDA 510(k)
FDA Class 2
·General Hospital
DR FOG TREATED SPONGE, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·July 29, 2021
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
SCRDRIVERSHAFT-1.5/2 CRUCIF SELF-HOLD L9
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·June 21, 2013
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·September 30, 2008
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
ALINITY C MAGNESIUM
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JGJ·February 16, 2026
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025