35 results · 22ms · Sources: EU EUDAMED, US FDA

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uCT ATLAS with uWS-CT-Dual Energy Analysis

FDA 510(k)
FDA Class 2 ·Radiology

VEO® Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996133333·LATERAL,OSTEOTOME,12

DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BRIVO XR385

FDA 510(k)
FDA Class 2 ·Radiology

BIOLOX DELTA MODULAR CERAMIC HEAD 36MM

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code LZO·December 30, 2016

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022

BD INSTRUMENT MAX CLINICAL

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code OOI·September 21, 2020

DUAL AIRWAY TEMPERATURE PROBE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·October 17, 2008

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTP·July 2, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 7, 2022

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 9, 2022

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 8, 2022

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 8, 2022

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 8, 2022

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 8, 2022

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 17, 2022

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FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 1, 2022