12 results
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18ms
·
Sources: EU EUDAMED, US FDA
ANEUVYSION
FDA 510(k)
FDA Class 2
·Immunology
SpinCon
FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102394·Para-Pak SpinCon is a unique, patented system f...
artegral
FDA UDI
Merz Dental GmbH·D7091972200·posteriors; shade A2 light; size XL; upper jaw
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM
STIMLAB
FDA 510(k)
FDA Class 2
·Cardiovascular
3880 MRI Patient Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE FILTER BLUNT FILL 18X1-1/2
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 28, 2020
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Death
·MPRI·Product code DTB·February 21, 2013
ARTELON CMC SPACER
FDA Adverse Event
Injury
·ARTIMPLANT AB·Product code KYI·January 18, 2011
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·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, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ·June 15, 2006
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020