10 results
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25ms
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Sources: EU EUDAMED, US FDA
PHADIRECT STREP A TEST
FDA 510(k)
FDA Class 1
·Microbiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199403·Revision Knee Spiral Reamer- Hudson Long Flutes...
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106532·ADSON DRESSING FORCEPS SERRATED DELICATE
MEDICAL OPTICS PHACOEMULSIFICATION KIT
FDA 510(k)
FDA Class 2
·Ophthalmic
STRIP SPLITTER II -HALF WIDTH CARRIER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2014
GYRUS ENT
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code GEI·October 26, 2012
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code LXH·September 3, 2010
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017