20 results · 23ms · Sources: EU EUDAMED, US FDA

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CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021

n/a

FDA UDI
HANS RUDOLPH, INC.·00874750006458·2200 15MMID MPORT/10.5MMOD I/E

Medetz Surgical Instruments

FDA UDI
Medetz Surgical Instruments LLC·G2231124730·Utility scissors, straight blades with blunt ti...

MULLINS-X PTV CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT

FDA 510(k)
FDA Class 2 ·Dental

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 15, 2025

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

CAREASSIST BED

FDA Adverse Event
Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·April 28, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025