15 results · 20ms · Sources: EU EUDAMED, US FDA

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NovoFine® Plus

FDA 510(k)
FDA Class 2 ·General Hospital

Regatta Lateral System

FDA UDI
Seaspine Orthopedics Corporation·10889981158996·Lateral Implant, 23mm x 12mm x 55mm, 10 Deg

Regatta Lateral System

FDA UDI
Seaspine Orthopedics Corporation·10889981159009·Lateral Implant, 23mm x 12mm x 55mm, 15 Deg

RRx Knee Tibial Cone Augment Reamer Size Large

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215147860·

TSolution® One Total Knee Application

FDA 510(k)
FDA Class 2 ·Neurology

Surgical Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 26, 2022

Vu aPod™ - L

FDA UDI
Seaspine Orthopedics Corporation·10889981046712·LATERAL IMPLANT, WIDE, LORDOTIC, 12mm X 23mm X ...

T:SLIM G4 SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OYC·June 21, 2018

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·April 14, 2011

GE OEC 9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·September 1, 2011

UNKNOWN DEPUY BONE CEMENT

FDA Adverse Event
Injury ·9610921 DEPUY CMW·Product code LOD·July 17, 2013

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025