10 results
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19ms
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Sources: EU EUDAMED, US FDA
RAPIDO-LASTIC IN STERILE FORM
FDA 510(k)
FDA Unclassified
·Unknown
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYSTEMS INTEGRATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code DQY·June 9, 2006
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 20, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 6, 2012
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH. LTD. / HUNTINGTON·Product code HQL·August 27, 2010
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781270
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021