12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LEAD, SUTURELESS MYOCARDIAL
FDA 510(k)
FDA Class 3
·Cardiovascular
MGB Alert HSV 1&2 Typer Probe Mix ASR - 480 rxn
FDA UDI
Elitechgroup Mdx LLC·03661540951398·MGB Alert® HSV 1 & 2 Probe Mix is an analyte sp...
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left
ACUMED
FDA UDI
Acumed LLC·10806378041488·.045" Locking Drill Guide 4-32mm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306810152·Micro Khouri Harvester, 12G x 15cm, Luer
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
FDA 510(k)
FDA Class 2
·Neurology
PROMUS PREMIER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 8, 2014
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·October 16, 2012
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 28, 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