18 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CIRCUL8 Connect DVT Prevention Device
FDA 510(k)
FDA Class 2
·Cardiovascular
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025033·G95 Mini Incubator
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·January 8, 2023
POWER TEK II
FDA 510(k)
FDA Class 2
·Orthopedic
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 30, 2021
ASCENSIA BREEZE2 TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·October 31, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORPORATION·Product code LLZ·July 8, 2013
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 2, 2019
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·January 6, 2023
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·January 6, 2023
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·January 6, 2023
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·January 8, 2023
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·January 8, 2023
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·January 6, 2023
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·December 1, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025