11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEAR+BRILLIANT TOUCH® Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASO Speed Lacer II Ankle Stabilizer w/Stays
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357236473·
GLENOID DRILL SMALL/STD/LARGE
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code KWT·June 14, 2023
CADENCE PEEK CEMEENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
4.2MM TROCAR 210MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·April 26, 2021
QUICKSITE LV
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
ADVIA CENTAUR CP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJE·August 25, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026