12 results · 21ms · 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.

EXEL DENTAL NEEDLE

FDA 510(k)
FDA Class 1 ·Dental

PREMIER(TM) Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902500329·PLATE 6861150 50 MM ANT CERV PLATE

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011861150180·Medium-Assortment Standard Bands, Tooth 44/34, ...

Screw, Cannulated,7.0x150mm, Full Thread

FDA UDI
Pioneer Surgical Technology, Inc.·00846468041380·7.0x150mm, Full Thread

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011861150220·Medium-Assortment Standard Bands, Tooth 44/34, ...

GALLENAUGH BONE PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES

FDA 510(k)
FDA Class 2 ·Hematology

EXTERNAL TEMPORARY PACEMAKER

FDA Adverse Event
Injury ·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014

ALTRUA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 8, 2010

TREATMENT RECLINER

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FRJ·November 2, 2012

Vanguard XP Tibial Tray 65 mm Item # 195246

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012