131 results · 36ms · Sources: EU EUDAMED, US FDA

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DiLumen C2; DiLumen Tool Mount

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Puritan Opti-Swab

FDA UDI
Puritan Medical Products·30609576900144·Opti-Swab 1ml Liquid Amies Transport Medium w/ ...

RESUSCITATION UNIT 105

FDA 510(k)
FDA Class 2 ·Anesthesiology

STARLIGHT, MODEL PD9012

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·July 22, 2015

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 3, 2026

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 18, 2015

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 1, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 28, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 6, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·August 18, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 7, 2025

PENUMBRA SYSTEM JETD REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·May 8, 2019

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 20, 2026

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026

PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·October 30, 2015

PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

FDA Adverse Event
Injury ·PENUMBRA, INC.·Product code NRY·June 14, 2015

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026