10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BEAVER MICRO-GEM GAUGE BLOCK
FDA 510(k)
FDA Class 1
·Ophthalmic
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148603050·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127299·18x15x5mm, 7 Degree Trial
HAIRMAX LASERCOMB
FDA 510(k)
FDA Class 2
·Physical Medicine
neoBLUE® LED Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
PROTECTA XT DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
OLYMPUS ALLIGATOR JAW-STEP
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KGE·November 16, 2012
VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 22, 2015
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023