8 results
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19ms
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Sources: EU EUDAMED, US FDA
DENTAL AMALGAM ALLOY
FDA 510(k)
FDA Class 2
·Dental
1st Glove Blue Nitrile Examination Gloves Powder Free
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·May 20, 2014
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 25, 2016
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·June 5, 2015
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
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