10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPL hair removal
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MST/Dewey .9mm A1 Bent Ph Tip 45deg
FDA UDI
MICROSURGICAL TECHNOLOGY, INC.·00844685000296·
DURACON CS TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 24, 2022
BD PEGASUS¿ SAFETY CLOSED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·January 11, 2022
MCA SMALL APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·August 24, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 9, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024