13 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IOLMASTER
FDA 510(k)
FDA Class 2
·Ophthalmic
artegral life
FDA UDI
Merz Dental GmbH·D7091993357·anteriors; shade C2; mould UIM
CLEARVIEW HCG DEV(URINE)20T
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 22, 2024
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
V-Mix
FDA 510(k)
FDA Unclassified
·Unknown
CLEARVIEW HCG DEV(URINE)20T
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 6, 2025
PERCUFLEX URETERAL STENT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FAD·June 15, 2006
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 7, 2013
INVISALIGN SYSTEM
FDA Adverse Event
Other
·ALIGN TECHNOLOGY, INC.·Product code NXC·February 7, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 2014
ALERE HCG CASSETTE
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·May 25, 2023
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020