17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
N PROTEIN STANDARD UY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CD 3700 SL
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007
PRIMER PLUS
FDA 510(k)
FDA Class 2
·Dental
OptikView GUP2103CMI
FDA 510(k)
FDA Class 2
·Radiology
MICROTAINER SST GOLD
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·June 7, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 1, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 16, 2018
MICROTAINER SST GOLD
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD·Product code JKA·May 7, 2018
BD MICROTAINER® EDTA LAVENDER TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·April 27, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 3, 2018
BD MICROTAINER® BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·December 3, 2017
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code LWP·August 8, 2014
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025