10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
Oticon
FDA UDI
Oticon A/S·05707131339799·SIYA 1, KIT 312 NFM 90 PB R C001
PSYCHEMEDICS CANNABINOIDS EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
FDA 510(k)
FDA Class 2
·General Hospital
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
WALLSTENT BILIARY STENT W/ UNISTEP PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·October 1, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
K-WIRE CUTTING PLIERS (MAX 1.6MM)
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·July 22, 2011
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020