13 results
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29ms
·
Sources: EU EUDAMED, US FDA
MODEL MBA-130 MOBILE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
K2-HF BLEACH DENTINE, BD-1, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621180·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862118180·Standard Band, Tooth 45/35, Size 18/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862118220·Standard Band, Tooth 45/35, Size 18/Roth 22
POINTE 360
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BEAR 2 ADULT VOL. VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
EASYTRAK
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 8, 2010
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 7, 2012
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·November 6, 2019
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·November 20, 2019
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·October 22, 2019
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