16 results
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23ms
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Sources: EU EUDAMED, US FDA
CARDIOVASCULAR DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
Traverse
FDA UDI
Nuvasive, Inc.·00887517152947·Traverse Plate, Size 45 Fixed
Dynamed CPR Mask, Green
FDA UDI
Laerdal Medical AS·07045430043947·The Dynamed CPR Mask is primarily designed for ...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117512·
Suction Cannula
FDA UDI
KOROS U.S.A., INC.·10840199535023·Suction Cannula I.M.A. Small Tip 3.0mm, 30m 12"
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8038200450·EXTENDED DUAL WIDTH "Z" RETRACTOR SMALL
STILLE Scissors
FDA UDI
Stille AB·07332339201302·STILLE VASCULAR SUPERCUT SCISSORS 45° 18 cm 7 in
FEMORAL HAMMER SLIDING IMPACTOR
FDA UDI
Biomet Orthopedics, LLC·00887868047879·
Momentum
FDA UDI
Ulrich Medical Usa, Inc.·00814386025881·Navigated tap, Ø 4.5mm, cannulated, 1/4"-square
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LCS COM 3 PEG M/B PAT REP STD+
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code NJL·May 20, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
ANI [ A&I ] GROUP TAIWAN·Product code IOR·November 5, 2012
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·August 24, 2010
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012