17 results · 23ms · Sources: EU EUDAMED, US FDA

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SafeCross Transseptal Puncture and Introducer (TSP/I) System

FDA 510(k)
FDA Class 2 ·Cardiovascular

KIT BD MAX EXT ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·January 27, 2021

DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Neurology

PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW

FDA 510(k)
FDA Class 2 ·Radiology

HIRES 90K

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC.·Product code MCM·October 17, 2008

MAXIMO II VR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012