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

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3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90

FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131281746·H15V2, BTE 13 WL 100 SIL

SCANORA 3D

FDA 510(k)
FDA Class 2 ·Radiology

BARIREP

FDA 510(k)
FDA Unclassified ·Unknown

STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 1, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

PULSAR MAX

FDA Adverse Event
Malfunction ·GUIDANT CLONMEL IRELAND·Product code NVZ·July 6, 2011

STEALTHSTATION S7 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 6, 2013

ALTRUA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014

BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·January 13, 2016