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

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ASCENT XXL OPEN BOX FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00273051·

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00273561·

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361009351·PedFuse, Adjustable Cross Connector, Angled, 35mm

Baby Gorilla® / Gorilla® Plating System

FDA UDI
Paragon 28, Inc.·00889795145864·Ankle Fracture 360, 2.7/3.5 mm Screw Caddy, Base

SLEEPSTRIP DISPOSABLE APNEA SCREENER

FDA 510(k)
FDA Class 2 ·Anesthesiology

HORIZONS ERCP CANNULA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TRILOGY 202

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·December 12, 2025

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022

VENTED MICRO VOL.INLET, N/S

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

VALVE SET, EM2400

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022

VALVE SET, EM2400

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022

XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·March 13, 2013

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 28, 2011

AUTOTOME RX SPHINCTEROTOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 26, 2008

250 ML TPN BAG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

EXACTA-MIX 2400 COMPOUNDING SYSTEM

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code NEP·February 27, 2023

TRILOGY 202

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·October 13, 2023

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·June 12, 2018

OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·July 24, 2019