17 results · 29ms · Sources: EU EUDAMED, US FDA

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Honda Walking Assist Device

FDA 510(k)
FDA Class 2 ·Physical Medicine

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025561·Kocher-Langenbeck Retr, 80x12mm, 8 1/2"

ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS

FDA 510(k)
FDA Class 2 ·Immunology

PT2 VARIAN PROTON THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

QUADRA-P FEMORAL STEMS

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

KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

FDA Adverse Event
Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 21, 2011

DELTA CER INSERT 36IDX52OD

FDA Adverse Event
Injury ·9616671 DEPUY IRELAND·Product code KWA·June 21, 2013

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

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

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

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

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

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021