9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARD PCA II INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011
ANTICONVULSANTS III CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COTTONS 100% NATURAL COTTON TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025