8 results
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27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Monarch Platform
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AGXO
FDA UDI
Oticon A/S·05707131342683·G200, MINIRITE T 312 2.4G C091 AGXO
MODIFICATION TO CASPIAN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2013
WAGNER SL REVISION STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 8, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON SARL·Product code OTN·October 31, 2015
***CAT#: 9297A***LINVATEC***Arthroscopic Blade***4.8mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 193794***Expiration Date: 10/2011. ***CAT #: 9299A***LINVATEC***Arthroscopic Blade***4.2mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 193534***Expiration Date: 10/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009