12 results · 35ms · Sources: EU EUDAMED, US FDA

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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