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

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White ENDOSEAL MTA

FDA 510(k)
FDA Class 2 ·Dental

Dornier MedTech

FDA UDI
Dornier MedTech GmbH·04049958002090·Medilas D30 1064 Diode Laser, SMA

NightGuard Flex

FDA UDI
Sprintray, Inc.·00850039704062·Indicated for the fabrication of orthodontic an...

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193113470·HA PEEK EVOS Straight, ,15mmx8mmx 30mm , FLAT ...

10PW - General Purpose

FDA UDI
Certified Safety Manufacturing, Inc.·00766588020129·10PW - General Purpose

SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BD ECLIPSE¿ NEEDLE WITH SLIP-TIP HUB CONFIGURATION

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 22, 2023

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

STRETCHER CHAIR

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 2, 2013

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 15, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 15, 2022