15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRIBRID® Unicompartmental Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Capo Slow Flow capsules A 3, 20 x 0.25
FDA UDI
Schütz Dental GmbH·ESDG2321141·Capo Slow Flow is a light-curing, flowable, hig...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112830·BARRON VACUUM PUNCH 9.5MM
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·October 18, 2012
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145201·R CR UHMWPE Ultracongruent Tibial Insert Sz A 14mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124541·R Ultracongruent Tibial Insert Trial Sz A 14mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101535·R E-MAXTM Vitamin E Ultracongruent Tibial Inser...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102303·R CR MAXTM HXL Ultracongruent Tibial Insert Sz ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523164561·R Ultracongruent Tibial Insert Trial with Anter...
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·December 26, 2012
HANDLES DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·November 4, 2008
UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED)
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 1, 2011
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 17, 2013