31 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NC TREK RX CORONARY DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176162137·Carbide bone cutter CA 2,6 mm coat
Mako
FDA UDI
MAKO SURGICAL CORP.·00848486016869·Integrated Cutting System Sagittal Blade - Narrow
TRESTLE LUXE
FDA UDI
ALPHATEC SPINE, INC.·00190376215198·TRESTLE LUXE II, ACP, 1-LEVEL, 34
ColoFlex™ UHD
FDA UDI
MAUNA KEA TECHNOLOGIES·03760187910055·
Posted Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D9091101341·.018 POSTED SS RIGHT FORM WIRES 34MM (10)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450227565·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539647·Spurling Laminectomy Ronguer upwards ang
led, 5...
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 23, 2022
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
FDA 510(k)
FDA Class 1
·Ophthalmic
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Arthrex®
FDA UDI
ARTHREX, INC.·00888867427860·Cannula w/ Oblique Window:11 x 134mm
CANNULA W/ OBLIQUE WINDOW:11 X 134MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·July 2, 2024
BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 9, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 2, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 15, 2021
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·February 11, 2013
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 13, 2013
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM·Product code NDJ·September 23, 2014