19 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Torcon NB Advantage Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659054·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659177·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659238·Automatic Disposable Biopsy Needle
Oticon
FDA UDI
Oticon A/S·05707131305213·RIA PRO, KIT MINIRITE 312 WL CBE
ADAPTER-1
FDA UDI
Aktormed GmbH·04260463848229·
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
FDA 510(k)
FDA Class 1
·General Hospital
Zavation
FDA UDI
Zavation LLC·00842166123168·Cage - 16x18mm, 22-34mm, 0°
Zavation
FDA UDI
Zavation LLC·00842166123199·Cage - 16x18mm, 22-34mm, 15°
Zavation
FDA UDI
Zavation LLC·00842166123175·Cage - 16x18mm, 22-34mm, 5°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929036884·Corpectomy, 16Dx18Wx22H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065839·Corpectomy, 16Dx18Wx22H 0°
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code MFK·July 8, 2011
RAD-5 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 24, 2014
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
FDA Enforcement
Class III
·Terminated·Diagnostica Stago, Inc.·September 24, 2014
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
FDA Enforcement
Class II
·Terminated·Enztec Limited·February 3, 2021