24 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ISO FUNCTIONAL
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994325556·CONNECTOR 7022430 LAT CONN SS 6.35 32MM
Safco SuperSorb Plus
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310224303·Safco SuperSorb Plus sponges, 2" x 2", 200/box,...
Reicodent
FDA UDI
devemed GmbH·04061644061563·REIC-aspir 2 | Basic suc. tube | 16.0cm
with ho...
Reicodent
FDA UDI
devemed GmbH·04061644061570·REIC-aspir 2 | Suction cannula tip Ø2.5mm
Inser...
Reicodent
FDA UDI
devemed GmbH·04061644061648·REIC-aspir 2 | Suction cannula tip Ø4.0mm
Inser...
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·September 24, 2022
SOL-MILLENNIUM
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025
FR MARSEILLE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·March 22, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 16, 2011
COBAS MIRA PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2008
UNK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·September 24, 2022
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·September 24, 2022
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·September 24, 2022
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