13 results
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20ms
·
Sources: EU EUDAMED, US FDA
ENCIRCLE COMPRESSION THERAPY STOCKING
FDA 510(k)
FDA Class 2
·General Hospital
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 48cm x 130°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665023510·
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
RE-TRACE URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Injury
·ANGIOSCORE, INC·Product code LIT·March 29, 2016
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code OTN·May 8, 2013
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·September 22, 2014
DUNLAP
FDA Adverse Event
Other
·KAZ, INC.·Product code IRT·August 14, 2008
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 26, 2015
MANTIS REDUX BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·November 27, 2019
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017