9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LDH-L REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Conceive Plus
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008426·Fertility Lubricant
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
FDA 510(k)
FDA Class 2
·Orthopedic
MAC Medical D-Series Blanket and Solution Warming Cabinets
FDA 510(k)
FDA Class 2
·General Hospital
BOM 7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GCJ·April 9, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 20, 2012
REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/140
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·April 28, 2022
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025