18 results · 24ms · Sources: EU EUDAMED, US FDA

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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