10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ProteXsure Safety Capsule System
FDA 510(k)
FDA Class 2
·General Hospital
Secondary Impactor
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076245·
BREATHEX OMEGA CPAP DEVICE, MODEL 322
FDA 510(k)
FDA Class 2
·Anesthesiology
PICCOLO COMPOSITE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014
AC ADAPTER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020