16 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Washbon
FDA UDI
ORMCO CORPORATION·00889989043747·UPPER LEFT FIRST MOLAR WASHBON BAND SIZE 13
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127673·Drill Tip Steinman Pin
ZIMMER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HTG·April 22, 1997
REGISTRATION AND FUSION
FDA 510(k)
FDA Class 2
·Radiology
PACER SYSTEMS ANALYZER (CORDIS)
FDA 510(k)
FDA Class 2
·Cardiovascular
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·TRI POL 43R HYDROPHILIC CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·TRI POL 43 CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·TRI POL 43 CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·TRI POL 43 CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 6, 2014
THINLINE
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 10, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 2, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025