14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
URETHRAL SOUND
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIVA BOND
FDA UDI
SDI LIMITED·09336472018245·RIVA BOND LC P/L KT
Polishers
FDA UDI
DFS - DIAMON GmbH·04057176152220·2ceram polisher flame RA
RIVA BOND
FDA UDI
SDI LIMITED·DO3688006101·
ACUMED
FDA UDI
Acumed LLC·10806378043413·Removal Tip Shaft, QR
NANCY NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868032844·
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127026744·Shortened Dual Taper Broach, Size 10
ARTHROCARE ORTHOWAND SURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESOLUTION CHOLESTEROL MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 8, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FNL·August 3, 2010
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