10 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENTORR ARTERIAL PRESSURE SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Sasmar Melon
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008303·PERSONAL LUBRICANT
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014
ISOTONIC BUFFERED SALINE
FDA 510(k)
FDA Class 1
·Hematology
Reuter Tip Deflecting Wire Guide
FDA 510(k)
FDA Class 2
·Cardiovascular
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·April 9, 2014
PARADYM
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA C.R.M., S.R.L.·Product code NIK·October 1, 2010
MINIARC PRECISE SINGLE-INCISION SLING
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 13, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025