11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Comprehensive Segmental Revision System (SRS)
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100844·MCNEILL GLOBAL FIXATION RING SMALL
IDEAL IQ SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Radiology
LITEDUO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 15, 2014
PWRD ECH FLEX 60MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 23, 2011
REVERSE SHOULDER SYSTEM HUMERAL DIAPHYSIS CEMENTLESS SIZE 8
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 7, 2019
REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 30, 2019
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016