8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED RLV-2100 B
FDA 510(k)
FDA Class 2
·Cardiovascular
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROFILE URODYNAMIC MONITORING SYS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 10, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·October 6, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 10, 2012
PLATE GC LECT AGAR 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JTY·March 29, 2021
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024