10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
M.A.G. INC. COAXIAL CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123816·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 125mm
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
FDA 510(k)
FDA Class 2
·Orthopedic
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
MENTOR MEMORYGEL BOOST BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·May 15, 2025
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·December 30, 2010
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 17, 2014
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·December 27, 2012
PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. 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