12 results
·
35ms
·
Sources: EU EUDAMED, US FDA
MEDICAL COMPARTMENT KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Polishers
FDA UDI
DFS - DIAMON GmbH·04057176152251·2ceram polisher flame RA
ACUMED
FDA UDI
Acumed LLC·10806378043703·Big Acutrak® Screw Instrument Tray
NANCY NAIL AND ENDCAP KIT
FDA UDI
Biomet Orthopedics, LLC·00887868032899·
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
FDA 510(k)
FDA Class 2
·General Hospital
M5 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 8, 2014
N/A
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code NLQ·October 22, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 7, 2007
Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121
FDA Recall
Terminated
·Biosite Inc·Product code MCB·December 4, 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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015