12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
FDA 510(k)
FDA Class 2
·Cardiovascular
Fibula Plate 3.5mm
FDA UDI
I.T.S. GmbH·09120047298312·Fibula Plate 3.5mm, 8-Hole, Left
TRIMAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD DISCARDIT¿ II - 2-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 21, 2023
BD DISCARDIT¿ II - 2-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 21, 2023
BD DISCARDIT¿ II - 2-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 21, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 15, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026