8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOFACT VIII
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 17, 2024
ASPHERE M SPEC 12/14 36 +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·June 3, 2013
SINGLEEXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·June 28, 2011
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022