11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PLASTIC STRIP BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135837·
Trephine
FDA UDI
BICON, LLC·00813110025838·3.75mm Trephine (4.6mm OD)
AVEA VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·October 23, 2012
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2010
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022