15 results · 26ms · Sources: EU EUDAMED, US FDA

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GENDEX 765DC, MODEL 110-0154

FDA 510(k)
FDA Class 2 ·Dental

CAPSTONE PTC™ Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169187429·SPACER 3992610 26MM X 10MM

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198819·AK3 Ultra Insert Trial Size 6, 10mm

KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

FDA 510(k)
FDA Class 2 ·Immunology

MODIFICATION TO BEACON STABILIZATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

WALLSTENT RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

PREMIER ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015

LEAD 3876-45 OCTAD 1X8 SC

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·March 7, 2013

CAPSUREEPI

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code DTB·August 8, 2014

CAPSURE SP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

WALLSTENT? RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020