7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
AEON Endoscopic Powered Stapler
FDA 510(k)
FDA Class 2
·General Hospital
BCR-30-min BI and RBIP-ST30 Readout Accessory
FDA 510(k)
FDA Class 2
·General Hospital
JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP
FDA 510(k)
FDA Class 1
·Physical Medicine
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 14, 2014
FOXCROSS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·September 16, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 29, 2013
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024