11 results
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18ms
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Sources: EU EUDAMED, US FDA
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746050022·WIRE SS POSTED UNIV 019 X 025 24MM 10/PK
Sphere Introducer
FDA UDI
KATENA PRODUCTS, INC.·00841668110836·CARTER SPHERE INTRODUCER
UniTip Catheter
FDA UDI
Unisensor AG·07640172971833·
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
FDA 510(k)
FDA Class 2
·Neurology
CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM G5 SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OYC·December 5, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·October 7, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 6, 2012
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