9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Sex Gel
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NT/IT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 10, 2018
MINI-INFUSER RADIATION STERILIZED EXTENSION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 17, 2014
CURRENT RF DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·June 20, 2013
NDEHP LS TWN 2CLVE
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code FPA·July 7, 2011
Ingenia 1.5T S-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 Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021