10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
LACTI-QUANT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135714·
BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 7, 2023
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 23, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·May 26, 2015
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