12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Catheter Surface Flap Applicator Set (GM11011830)
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111077784·DEL WIRE SUTURE SCISS 4 1/2"
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 10, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 22, 2013
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code EYB·August 5, 2015
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
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