18 results · 20ms · Sources: EU EUDAMED, US FDA

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GLUCOSE TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

JOBST forMen Casual

FDA UDI
BSN MEDICAL, INC.·00035664131371·FM CASUAL 30-40 KH CT XLFC BL 1 EN FR ES

Globe Scientific

FDA UDI
GLOBE SCIENTIFIC INC.·00840095601368·Cap, Snap with Sanitary Grip, PE, Yellow, for F...

Stryker

FDA UDI
Provision·B504OM6113137900·

NA

FDA UDI
STERILMED, INC.·10888551028158·SAW BLADE SAGITTAL SYSTEM 6 HEAVY DUTY

Stryker Performance Series

FDA UDI
STRYKER CORPORATION·04546540593337·Stryker Performance Series Sagittal Blade

Stryker Performance Series

FDA UDI
STRYKER CORPORATION·04546540501363·Stryker Performance Series Sagittal Blade

VENUS ANTERIOR CERVICAL PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

ALGO 3 NEWBORN HEARING SCREENER

FDA 510(k)
FDA Class 2 ·Neurology

OT VERIO FLEX METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·December 7, 2018

FREESTYLE LIBRE 2 PLUS

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code QBJ·May 23, 2026

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 9, 2013

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 22, 2014

ASR ACETABULAR CUPS 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

HEMOSIL HIT-AB(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

HEMOSIL HIT-AB(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

HEMOSIL HIT-AB(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021