10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CO2 LASER BRONCHOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640731·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
AMES/GILFORD OPTIMATE CLIN. CHEM & THER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GP-303
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTAIN STARFIX
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
SPRINT
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·October 8, 2010
TECNIS 1-PIECE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·December 7, 2012
END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
FDA Enforcement
Class III
·Terminated·Synthes (USA) Products LLC·November 11, 2020
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025