16 results · 23ms · Sources: EU EUDAMED, US FDA

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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