9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Nu-Edge Bracket
FDA UDI
TP ORTHODONTICS INC·00192029045916·LO UNIV 1st BI NO HK
Curette
FDA UDI
KATENA PRODUCTS, INC.·00841668102138·ANIS CAPSULE SCRUBBER DISC
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IHEALTH FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 28, 2013
CLARION
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·November 2, 2010
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 14, 2014
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LLZ·August 7, 2013