10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
FDA 510(k)
FDA Class 2
·Cardiovascular
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
FDA 510(k)
FDA Class 2
·Neurology
XCage Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
SURGICOUNT SAFETY-SPONGE SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
7.3MM CANNULATED SCREW 32MM THREAD/110MM
FDA Adverse Event
Malfunction
·Product code DZL·November 1, 2012
STENOSCOPE
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·September 17, 2010
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
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