9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STRATUS CS CKMB CALPAK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXSOS
FDA UDI
Stryker GmbH·07613154482702·X-Ray Template Compression Plate Narrow
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981097·anteriors; shade A3.5; mould IL2
Cook Cystostomy Catheter Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·February 27, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·August 5, 2014
CAPSUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 8, 2011
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