18 results · 20ms · Sources: EU EUDAMED, US FDA

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ACTICOAT 7 DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

TruForm

FDA UDI
Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001519·artVeneer life lower anteriors, UBL, D4

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756131889·Custom Anesthesia Circuit

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515008847·Sponge Bowl, 38oz 6.25" x 2.75"

Sonova Brand

FDA UDI
Sonova AG·07613389431704·Easy Line Remote 3.0 app

TI500 GLOBE-TROTTER TRANSPORT SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

GLUCANPRO

FDA 510(k)
FDA Unclassified ·Unknown

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 26, 2014

FREESTYLE

FDA Adverse Event
Injury ·Product code NBW·October 26, 2010

iBOT PMD with software version 01.05.24. Personal Mobility Device.

FDA Enforcement
Class II ·Ongoing·Mobius Mobility LLC·June 18, 2025

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 10, 2016

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

LUPINE DRILL BIT

FDA Adverse Event
Malfunction ·DEPUY MITEK·Product code HTW·January 26, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·February 20, 2008

TECNIS SIMPLICITY

FDA Adverse Event
Injury ·AMO PUERTO RICO MFG. INC.·Product code POE·May 28, 2025

Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

FDA Enforcement
Class II ·Terminated·ArthroCare Corporation·September 30, 2020

CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019