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

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Philips IntelliVue XDS Software

FDA 510(k)
FDA Class 2 ·Cardiovascular

MUSTMINI OCCIPITAL SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

DYNAREX ULTRASOUND GEL

FDA 510(k)
FDA Class 2 ·Radiology

CRANIAL PERFORATOR

FDA 510(k)
FDA Class 2 ·Neurology

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 27, 2023

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 5, 2019

POLYMOBIL PLUS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026

530G INSULIN PUMP

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

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

6000CMS

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 11, 2013

MOBILETT ELARA MAX

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020

MUSTMINI OCCIPITAL SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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