11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aidite PMMA
FDA 510(k)
FDA Class 2
·Dental
Sierra Wave
FDA UDI
CADWELL INDUSTRIES, INC.·00840067101209·Sierra Wave Stimtroller
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741337·House Strut Pick, malleable medium shaft, angl...
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
FDA 510(k)
FDA Class 2
·Cardiovascular
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·March 10, 2022
BD MICROLANCE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·September 13, 2019
SYNTHES
FDA Adverse Event
Injury
·SYNTHES·Product code HRS·October 7, 2008
6000CMS IO
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
Peripheral Diamondback 1.50 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