12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569653·CoRoent Ant TLIF Ti, 12x10x28mm 8°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A22302880·22mm H x 30mm W x 28mm L x 8 degrees ALIF
PADPRO, MODEL 2603
FDA 510(k)
FDA Class 3
·Cardiovascular
ORTHOCAD SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 30, 2024
HYDRA JAGWIRE GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EZB·November 3, 2008
TRILOGY CROSSLINKED POLYETHYLENE LINER
FDA Adverse Event
Injury
·ZIMMER·Product code LPH·August 16, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016