7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
FDA 510(k)
FDA Class 2
·Cardiovascular
ISSYS LP SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GLOBAL FX POROUS-COATED HUMERAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 11, 2013
ENSEAL TRIO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·October 18, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 2, 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