12 results
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19ms
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Sources: EU EUDAMED, US FDA
Triton System
FDA 510(k)
FDA Class 2
·General Hospital
Sizer Tower
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215046385·
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2013
SIGNATURE KNEE GUIDE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 13, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015