9 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CICA-CARE SILICONE GEL SHEET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·04260516872522·SIC Standard Abutment Ø 4.2 mm, anterior, strai...
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9358031·SIC Standard Abutment Ø 4.2 mm, anterior, strai...
DMA LD KINETIC PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HALE SUN SURGICAL TOWEL OR O.R. TOWEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 23, 2014
SPACEMAKER PREPERITONEAL DIST BALLOON
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·January 2, 2013
SYBRONPRO XRT
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·December 22, 2010
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021