11 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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Progressive Orthodontics App
FDA 510(k)
FDA Class 2
·Dental
Oticon
FDA UDI
Sbo Hearing A/S·05714464055753·OTICON MORE 1 MINIRITE R C063 DEMO
SHARPSAWAY II LOCKING DISPOSABLE CUP
FDA 510(k)
FDA Class 2
·General Hospital
LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
ELITE 14CM ANGLED ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·July 23, 2019
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM NON US
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 19, 2008
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·August 17, 2011
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 22, 2013
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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