14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021
BARD MALECOT AND PEZZER DRAINS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTRALCO
FDA 510(k)
FDA Class 1
·Clinical Toxicology
MIO ADVANCE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FPA·July 20, 2021
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
BD PEGASUS BL 22GA X 0.75IN QSYTE NON-PVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 7, 2024
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·June 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·June 22, 2011
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·December 30, 2025
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·June 10, 2025
TSRH® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code NKB·January 22, 2026