16 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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