13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OWL CANNULAE
FDA 510(k)
FDA Class 2
·Neurology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613021436·Lillie Ear Hook, 1mm Ball Tip, Angled 90 Degree...
PROFEMUR S HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
XTRA AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
INTIMA-II 20GAX1.16IN PRN SLM NPVC
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 9, 2019
INTIMA-II 20GAX1.16IN PRN SLM NPVC
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·September 25, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
NAVIGATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EYB·June 10, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·August 29, 2008
XTRA AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code CAC·August 2, 2021
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012