12 results
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18ms
·
Sources: EU EUDAMED, US FDA
PRODIGY AND PRODIGY PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482332·PLATE 6860167 67.5MM ANTERIOR CERVICAL
ATRIA 3100, ATRIA 6100
FDA 510(k)
FDA Class 2
·Cardiovascular
DePuy Synthes TFNA Augmentation System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
PALACOS R BONE CEMENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LOD·November 21, 2012
ALLEGRETTO WAVE
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·September 21, 2010
TFNA FEM NAIL Ø10 R 125° L320 TIMO15
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018
10MM/125 DEG TI CANN TFNA 200MM - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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