1,688 results · 21ms · Sources: EU EUDAMED, US FDA

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Smileyscope System (Therapy Mode)

FDA 510(k)
FDA Class 2 ·Neurology

AZURE ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MPM-NET

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOLUSET 150 X 60 BURETTE SET, LATEX FREE

FDA Adverse Event
Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPK·November 6, 2008

AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

FDA Adverse Event
Injury ·C.R. BARD, INC.·Product code FTL·August 23, 2011

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 8, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 8, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 30, 2025

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 15, 2025

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·February 19, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 27, 2026

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 26, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026