18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONOBLOC REAMER 10.5mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000832·
Curette
FDA UDI
KATENA PRODUCTS, INC.·00841668102121·SCORSETTI-SHEPHERD POLISHER
Sklar®
FDA UDI
SKLAR CORPORATION·10649111139826·SKLARLITE OP SCISS SB ST 5
Epilaser Absolute
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ear-Friendly Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRESENIUS
FDA Adverse Event
Injury
·FMC·Product code FJK·February 17, 2000
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 7, 2024
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 7, 2024
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 7, 2024
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 26, 2011
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 21, 2008
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 12, 2013
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023
BD CONVENTIONAL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 20, 2024
SYNERGY VERSITREL
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 11, 2015
BD CONVENTIONAL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 23, 2024
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021