9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONE DROP Lancing Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Compressor Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357238156·
C-1805M
FDA 510(k)
FDA Class 1
·Dental
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·August 19, 2011
VESSEL LOOP, RED, MAXI, NON-STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, INC.·Product code KDC·July 2, 2013
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018