12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
FDA 510(k)
FDA Class 2
·Hematology
P.F.C.
FDA UDI
DEPUY (IRELAND)·10603295215431·P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 2...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860122000·Standard Band, Tooth 15-14/24-25, Size 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860122220·Standard Band, Tooth 15-14/24-25, Size 22/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860122180·Standard Band, Tooth 15-14/24-25, Size 22/Roth 18
SLEEP SPLINT
FDA 510(k)
FDA Class 2
·Dental
WILL-CERAM Y-2
FDA 510(k)
FDA Class 2
·Dental
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 29, 2012
SUPER LIGHT ROLLATOR
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, INC.·Product code ITJ·June 18, 2015
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
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