8 results
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22ms
·
Sources: EU EUDAMED, US FDA
DIGIKIT NONPNEUMATIC TOURNIQUET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO: VACLOK SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
ATTAIN ABILITY STRAIGHT
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·December 4, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 21, 2010
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012