12 results
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33ms
·
Sources: EU EUDAMED, US FDA
CPI MODEL 2215 & SEAMED MODEL 3400
FDA 510(k)
FDA Class 2
·Cardiovascular
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981081621·Thin Tip Distractor
Scissor
FDA UDI
KOROS U.S.A., INC.·10840199539229·Metzenbaum Scissors Delicate Tungsten Carbide B...
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
FDA 510(k)
FDA Class 2
·Orthopedic
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·April 25, 2014
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code NPJ·April 25, 2014
ENDOWRIST PROGRASP FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·April 9, 2014
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·January 13, 2013
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·November 19, 2010
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025