17 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device

FDA 510(k)
FDA Class 2 ·Orthopedic

OCTARAY Mapping Catheter

FDA UDI
Biosense Webster Inc·10846835021134·OCTA,GALAXY,3-3-3-3-3,F-CURVE

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321609060·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311609060·

CALYPSO 4D LOCALIZATION SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

APEX SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 5, 2022

FARAPULSE PFA SYSTEM AND FARAWAVE PULSED FIELD ABLATION (PFA) SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code QZI·June 13, 2025

FARADRIVE SHEATH

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRA·July 18, 2025

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

CONCERTO

FDA Adverse Event
Malfunction ·WAVELIGHT GMBH·Product code LZS·June 16, 2011

EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code FGE·June 6, 2008

OCTA,LNG,48P,3-3-3-3-3,F-CURVE

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code MTD·January 10, 2024

VARIPULSE¿ BI-DIRECTIONAL CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code QZI·February 5, 2026

QDOT MICRO

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code OAE·November 13, 2025

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code EGS·September 29, 2016

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018