12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MO8 OXYGEN FLOWMETER
FDA 510(k)
FDA Class 1
·Anesthesiology
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002559·VITROS Chemistry Products AAT/HPT Performance V...
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113288·STAB KNIFE 22.5 DEGREE (BX/5)
ACUMED
FDA UDI
Acumed LLC·10806378096334·Lateral Fibula Targeting Block R
EXSUDEX WOUND DRAINAGE PUMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
450 DRILL/800 DRILL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 9, 2014
RETROFLEX 3 INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·October 24, 2012
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·August 17, 2010
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017