24 results · 21ms · Sources: EU EUDAMED, 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