12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3M™ ESPE™
FDA UDI
3M COMPANY·30605861030930·3M™ ESPE™ Gold Anodized Crown Refills, First Mo...
VARIAX
FDA UDI
Stryker GmbH·07613327129014·Grey Blank Clip
N/A
FDA UDI
Tyber Medical, LLC·M695M9403460·
NobelProcera Zirconia Implant Bridge
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO ORIA TOP CLIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 3, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 20, 2010
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 17, 2014
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 16, 2018
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015