20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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