16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NeoBeat, NeoBeat Mini
FDA 510(k)
FDA Class 2
·Cardiovascular
DePuy Mitek
FDA UDI
Provision·B504OM2321110·
NA
FDA UDI
Medos International Sàrl·10886705011001·ACL GRAFT KNIFE 11mm
Capo Bulk Fill Compules
FDA UDI
Schütz Dental GmbH·ESDG2321111·Light-curing, flowable dental filling composite
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112809·BARRON VACUUM PUNCH 8.75MM
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184262·R CR E-CIMA Vitamin E Ultracongruent Tibial Ins...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184507·R Ultracongruent Tibial Insert Trial Sz A 11mm
ACUSON CV70 CARDIOVASCULAR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·December 7, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·November 30, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·September 8, 2020
LIFEPAK EXPRESS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·November 4, 2008
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 1, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 17, 2013
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021