12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TEC 2101 (MODEL MT-HPLGD)
FDA 510(k)
FDA Class 1
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122970·K-WIRE - SINGLE TROCAR 1.1mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156050·K-WIRE - SINGLE TROCAR 1.1mm DIA x 230mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150768·K-WIRE - SINGLE TROCAR 1.6mm DIA x 230mm
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIESOMETER, MODEL MK-1
FDA 510(k)
FDA Class 2
·Cardiovascular
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 31, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·December 29, 2010
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 17, 2014
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025