12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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