11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
L-15 MEDIUM (MODIFIED)
FDA 510(k)
FDA Class 1
·Hematology
BD SINGLE USE, HYPODERMIC SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
PERIOLASE ND:YAG DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD LUER SLIP¿ TUBERCULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
BMU 40 BLOOD MONITORING UNIT
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DRY·March 21, 2014
ORCHESTRA
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code KRG·June 2, 2015
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 27, 2021
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 Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
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