12 results · 21ms · Sources: EU EUDAMED, 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