8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHEMO-PORT
FDA 510(k)
FDA Class 2
·General Hospital
H.R. JAKOBI SURG. INSTRUMENTS #11 38/67
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB
FDA 510(k)
FDA Class 2
·Radiology
BIVONA
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·September 1, 2020
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·April 23, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2010
FOXCROSS PTA CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LIT·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024