12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MANTIS Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004109·Luna Opal MB Mini .022 LR5 D/HK (-17°T +2°A)
ARTHREX MIXING AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
FDA 510(k)
FDA Class 2
·Radiology
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ABS2000
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 3, 2008
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
ESSURE
FDA Adverse Event
Malfunction
·CONCEPTUS, INC.·Product code HHS·October 23, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·August 23, 2011
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·July 11, 2013
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
FDA Enforcement
Class II
·Completed·IMMUNDIAGNOSTIK, Inc·May 24, 2023
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018