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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

RENAMEL PACK

FDA 510(k)
FDA Class 2 ·Dental

artegral life

FDA UDI
Merz Dental GmbH·D7091993659·anteriors; shade BL4; mould UBIS

ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5

FDA 510(k)
FDA Class 2 ·Cardiovascular

iTero Element 5D

FDA 510(k)
FDA Class 2 ·Dental

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 11, 2015

SINGLE SITE PORT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 7, 2013

SPRINT

FDA Adverse Event
Injury ·MPRI·Product code LWS·August 8, 2014

DURAL ALPHA INSERT W RIM II/32

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code LPH·March 12, 2019

DURASUL, ALPHA INSERT, HOODED, II/32

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LPH·September 28, 2018

METASUL, ALPHA INSERT, JJ/28

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWA·February 4, 2019

DURASUL, ALPHA INSERT, KK/36

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·March 13, 2018

NASAL-AIRE

FDA Adverse Event
Malfunction ·INNOMED TECHNOLOGIES·Product code BYE·January 6, 2003

EVOLUT FX DCS

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NPT·November 10, 2025

COCR HEAD 32/ 0 'M' 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·June 4, 2019

DURASUL, ALPHA INSERT, LL/36

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·April 29, 2019

DURASUL, ALPHA INSERT, HOODED, KK/32

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code LPH·June 15, 2018

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024