10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDIMAGE
FDA 510(k)
FDA Class 2
·Radiology
artegral
FDA UDI
Merz Dental GmbH·D7091972215·posteriors; shade A3 light; size M; lower jaw
UNCONJUGATED ESTRIOL RIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TITANIUM POWERPORT ISP IMPLANTED PORT
FDA 510(k)
FDA Class 2
·General Hospital
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·February 21, 2013
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·January 19, 2011
ALTRX +4 NEUT 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·July 31, 2014
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·August 23, 2007
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026