9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SUPRAPUBIC TROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACUMED
FDA UDI
Acumed LLC·10806378043383·Impact Driver Handle
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127026713·Shortened Dual Taper Broach, Size 7
SOLO-CARE BRAND HARD SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SUTURE ANCHOR, PEEK SWI- VELOCK C, 4.75 X 19.1MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·May 8, 2014
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2012
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 7, 2007
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