12 results
·
29ms
·
Sources: EU EUDAMED, US FDA
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
FDA 510(k)
FDA Class 2
·Microbiology
NEUROMONICS TINNITUS TREATMENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Qlicksmart BladeFlask UNIVERSAL
FDA 510(k)
FDA Class 2
·General Hospital
LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 5, 2023
SL 1 INTRODUCER UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011
RESPONSE EP CATHETER UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 3, 2012
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·September 1, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025