11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ACE STAPLER, MODEL F0031
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
FDA 510(k)
FDA Class 2
·Ophthalmic
BI-PHASIC INFILTRATOR
FDA 510(k)
FDA Class 2
·General Hospital
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA Adverse Event
Other
·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 26, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·July 23, 2008
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014