16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODEL PC-860 FETAL DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740820550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674082055060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0820550·8mm H x 20mm W x 55mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X082055120·8mm H x 20mm W x 55mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L082055120·8mm H x 20mm W x 55mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08205580·8mm H x 20mm W x 55mm L x 8 degrees XLIF
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK
MEDS-4-INF+
FDA 510(k)
FDA Class 2
·Neurology
3.25MM SPLINE TWIST IMPLANT
FDA 510(k)
FDA Class 2
·Dental
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013
SOVEREIGN COMPACT
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS (AMO)·Product code HQC·April 26, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·July 23, 2008
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