24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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