14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Mepilex® Up
FDA UDI
Mölnlycke Health Care AB·07333350294755·Mepilex Up, 10x10 cm US
INSYTE AUTOGUARD BL 22GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 19, 2024
INSYTE AUTOGUARD BL 22GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 19, 2024
DIGICAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
FDA 510(k)
FDA Class 2
·Microbiology
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 3, 2025
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 6, 2025
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 26, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 29, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 15, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 9, 2013
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021