21 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PCT System
FDA 510(k)
FDA Class 2
·Orthopedic
Ceramic Liner Inserter Impactor Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039349·
DUREPAIR DURA REGENERATION MATRIX
FDA 510(k)
FDA Class 2
·Neurology
CRUISER 18 GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
ORS-300N SOLUTION WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·August 2, 2016
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·June 3, 2019
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HAW·April 19, 2017
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·July 24, 2019
TIBIAL INSERT FB SZ 3 RT 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·April 13, 2023
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014