9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TDM Plate and Screw Systems
FDA 510(k)
FDA Class 2
·Orthopedic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306822582·Bow Retractors without teeth, Width: 32 mm / 1....
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026
PULPDENT MICRO-HYBRID COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
DEPUY UNIVERSAL GRIPTION TF CONES
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·June 26, 2013
LANCET DEVICE MMT-385 SILSRTR EA 13L
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code KZH·July 28, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 16, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024