17 results · 20ms · Sources: EU EUDAMED, US FDA

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HANSAPOR STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

VuePoint

FDA UDI
Nuvasive, Inc.·00887517339591·VuePoint Cross Connector, Adjustable

ACP4 SPINAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

IntellaMap Orion High Resolution Mapping Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

RESTORE SENSOR

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·October 16, 2012

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 31, 2013

ADAPTA DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2010

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015