9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BALLOON DILATION HELICAL STONE EXTRACT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102282·ROSENWASSER DALK TRISECTOR
MENICON NECT CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
INTER-OS LIMB LENGTHENER
FDA 510(k)
FDA Class 2
·Orthopedic
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·June 10, 2020
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 6, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2015
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024