25 results · 23ms · Sources: EU EUDAMED, US FDA

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Blood Collection Accessory (BUCA)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BLUE SUI SLING

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

THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

QUADRA-P FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

MANUAL ORTHOPEDIC SURICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code LXH·September 18, 2008

VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021

TRULIANT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·July 14, 2025

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·March 17, 2022

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Injury ·COOK INC·Product code MMX·September 29, 2021

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·June 3, 2022

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·August 15, 2022

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MMX·January 30, 2023

GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

FDA Adverse Event
Injury ·COOK INC·Product code MMX·February 6, 2023