10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032430·Basin Set Craw. Long Heart
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·August 29, 2016
EPI-GUIDE BIORESORBABLE BARRIER MATRIX
FDA Adverse Event
Injury
·KENSEY NASH CORP.·Product code LYC·May 13, 2013
PALINDROME SAPPHIRE 33/50KT VT
FDA Adverse Event
Malfunction
·COSTA RICA COVIDIEN MANUFACTURING·Product code MSD·July 28, 2014
MANTIS ROD INSERTER INNER SHAFT
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·May 20, 2011
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024