14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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14HQ901G-B
FDA 510(k)
FDA Class 2
·Radiology
Avex CX
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205108111·Avex CX .018 LR3 D/HK (-6°T 3°A)
NA
FDA UDI
Synthes GmbH·10886982153548·4.5MM CORTEX SCREW 44MM
HAWKEYE™ Vertebral Body Replacement (VBR)
FDA UDI
Choice Spine, LP·00840996101035·VBR,SPACER,12X14X44,0 DEG
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113881·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 M...
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 7, 2025
PUMP MMT-722WWL PRDGM INSULIN CL EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LZG·October 23, 2008
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·August 2, 2011
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 3, 2013
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023