24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AESCULAP ABSORBABLE CRANIOFIX
FDA 510(k)
FDA Class 2
·Neurology
Leksell Vantage Stereotactic System
FDA UDI
Elekta Solutions AB·07340201501603·MRI COIL ADAPTER LARGE
Arthrex®
FDA UDI
ARTHREX, INC.·00888867521988·Cannulated Cancellous Screw, 7.0x80mm
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934070·Percutaneous Transluminal Angioplasty Balloon C...
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996190305·THUNDERBOLT,X-TAB SCREW,6.0X40X080
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933462·Percutaneous Transluminal Angioplasty Balloon C...
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996189705·THUNDERBOLT,X-TAB SCREW,5.0X40X080
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175306·Z-Rod, Dia. 5.5mm, Co-Cr, 80mm
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ASNIS III CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AROX 53-JBP
FDA Adverse Event
Other
·BIOTRONIK GMBH AND CO·Product code DTB·June 29, 2006
KAINOX SL 75/16
FDA Adverse Event
Other
·BIOTRONIK GMBH AND CO·Product code LWS·June 29, 2006
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 29, 2019
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 3, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 5, 2011
SIGNA TWINSPEED EXCITE
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code LNH·May 7, 2008
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 23, 2019
FUSION TITAN DILATION BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·May 4, 2018
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
FDA Recall
Terminated
·Product code NIP·May 23, 2016
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025