19 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AXSOS PLUS LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Catalyft PL Expandable Interbody System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000292188·ADAPTER 6061012 NAV TRIAL ADAPTER
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00610121·
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610121·Mini Sprint-Brackets 5-5 Roth .018" 100 Bracket...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193104317·HA PEEK EVOS Curved, , 12mmx11mmx 30mm , FLAT 6...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523178360·Plate Speed Guides, 10mm, Right
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523178391·Plate Speed Guides, 16mm, Right
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523178377·Plate Speed Guides, 12mm, Right
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523178384·Plate Speed Guides, 14mm, Right
DIGITAL INTEGRATION SYSTEM, DIS2000
FDA 510(k)
FDA Class 2
·Radiology
POWDER FREE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·October 2, 2012
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·April 16, 2013
HUDSON NASAL CANNULA CPAP SET, INFANT, SIZE 4
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZD·March 14, 2011
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIO·June 12, 2008
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022