8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNERGY TISSUE MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UPSYLON?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTO·June 3, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 27, 2014
ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JWH·June 29, 2011
SOLARICE RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·August 26, 2019
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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