18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Straumann CARES Screw-Retained Bridges and Bars
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584090152·CAPTO 7 B 105 FW 3.0
LH-75T PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 16, 2020
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026
AFFINITY THREE BIRTHING BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·June 11, 2013
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 18, 2014
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 30, 2011
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·February 14, 2018
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025