12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYLOX® ST
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114131·BIMANUAL IRRIGATION 21GA END OPEN PK/10
3.Omm Biomet Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ALCOHAWK PRECISION
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ASR ACETABULAR IMPLANT 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 12, 2011
*
FDA Adverse Event
Other
·DRAEGER MEDICAL AG & CO. KG·Product code CBK·November 18, 2008
EPIX UNIVERSAL CLIP APPLIER
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·July 19, 2013
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026
NEXUS® BONESCALPEL® 25MM BLUNT BLADE AND IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·February 27, 2025
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025