17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLACKSTONE PILLAR XL PEEK SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740822350·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674082235060·
Bard® Guidewires
FDA UDI
C. R. Bard, Inc.·00801741052859·Bard® Guidewires
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0822350·8mm H x 22mm W x 35mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08223580·8mm H x 22mm W x 35mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X082235120·8mm H x 12 mm W x 35mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L082235120·8mm H x 22mm W x 35mm L XLIF Trial 12 degree Lo...
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HORIZONS ERCP CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 26, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
ARTICUL/EZE BALL 32 +1 GR
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH·Product code JDI·April 29, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 9, 2011
ITREL 3
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code LNQ·July 25, 2008
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014