8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
FDA 510(k)
FDA Class 2
·General Hospital
OCHSNER 50 VASCULAR PROSTHESIS
FDA 510(k)
FDA Class 2
·Cardiovascular
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUSA EXCEL 23KHZ CEM NOSECONE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES IRELAND LIMITED·Product code LFL·May 27, 2014
INOMAX DS (DELIVERY SYSTEM)
FDA Adverse Event
Malfunction
·INO THERAPEUTICS LLC/IKARIA·Product code MRN·November 2, 2010
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 19, 2012
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·September 8, 2025
PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014