10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEDICAT*
FDA 510(k)
FDA Class 1
·General Hospital
REUSABLE LINEAR STAPLER HANDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PULSECO HEMODYNAMIC MONITOR CM71
FDA 510(k)
FDA Class 2
·Cardiovascular
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014
LIGACLIP MCA LARGE APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDO·November 12, 2007
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 31, 2012
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 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