8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MUCOPREN SOFT RELINING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
XableCath Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 28, 2013
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 10, 2011
14MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·August 6, 2014
INFOV.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024