11 results
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18ms
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Sources: EU EUDAMED, US FDA
7CM BERMAN AIRWAY
FDA 510(k)
FDA Class 1
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827905·ACHIMED ACHILLES SUPP BLACK II
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113300·PS Insert, Size 5 x 12mm
LEONE SPA
FDA UDI
LEONE SPA·08033707027935·WEB 1ST MOLAR BANDS n.UR 12
MTI ST#1 SILICONE PESSARY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Disposable Surgical Face Mask (M01, M02)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RA CATH SET: 20 GA X 1-1/2
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·April 11, 2014
E360 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICLA INSTRUMENT·Product code CBK·November 2, 2012
ANGIOGUARD RX
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NTE·August 30, 2010
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012