15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Endo SmartCap
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FareTec Compressed Gauze
FDA UDI
FARETEC, INC.·B54122230400·Compressed Gauze, 4.5"x4.1 yards stretched. (11...
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113646·RETROBULBAR NEEDLE 23GA 38MM
Ti-one 101
FDA UDI
HUNG CHUN BIO-S CO., LTD.·04719871590539·Abutment Ø6.5, 4.0 mm Abt. H
The Ti-one 101 Den...
Drive Rail System
FDA UDI
ORTHOPEDIATRICS CORP.·00817867020603·CLAMP, 4-HOLE IN-LINE
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295104858·GLOBAL CAP HUMERAL HEAD TRIAL 40mm x 18mm
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295104841·GLOBAL CAP HUMERAL HEAD TRIAL 40mm x 15mm
WU'S 3-WHEELED NEO SCOOTER, WT-L3
FDA 510(k)
FDA Class 2
·Physical Medicine
TSolution One Total Knee Application
FDA 510(k)
FDA Class 2
·Neurology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011
WHEELCHAIR COMPONENTS
FDA Adverse Event
UNKNOWN·Product code IOR·November 4, 2014
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 12, 2013
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 19, 2023
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024