11 results
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30ms
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Sources: EU EUDAMED, US FDA
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
FDA 510(k)
FDA Class 2
·Cardiovascular
PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
HEMOSTATIC/TUBE OCCLUDING FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
FDA Adverse Event
Injury
·ANGIODYNAMICS, INC.·Product code DRE·April 13, 2026
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·November 5, 2012
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·September 27, 2010
MINI STICK MAX COAXIAL MICROINTRODUCER KIT
FDA Adverse Event
Injury
·ANGIODYNAMICS, INC.·Product code DRE·May 11, 2026
THREE PEG PATELLA 38MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 10, 2024
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
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