14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
T2 Alpha Tibia Nailing System, IMN Screws System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568243·CoRoent Ant TLIF PEEK, 9x13x30mm 8°
LEONE SPA
FDA UDI
LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz
Orthos
FDA UDI
ORMCO CORPORATION·00889989030488·ORTHOS CM NITI ARCH16X22LOLG PK10
MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
FDA 510(k)
FDA Class 2
·Anesthesiology
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 23, 2025
ISOFLEX S
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 13, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 18, 2018
HANDLE ACETABULAR PRESS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025
ACETABULAR PRESSURIZER SMALL
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017