9 results
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17ms
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Sources: EU EUDAMED, US FDA
TONSIL SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANNE Sleep
FDA 510(k)
FDA Class 2
·Anesthesiology
LADARVISION
FDA Adverse Event
Injury
·Product code LZS·May 15, 2014
PINNACLE 300 ACET CUP 54MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·November 6, 2012
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA-OHIO, INC.·Product code HBL·August 24, 2010
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
FDA Enforcement
Class I
·Terminated·BERLIN HEART GMBH·May 31, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 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