14 results · 16ms · Sources: EU EUDAMED, US FDA

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OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE

FDA 510(k)
FDA Class 1 ·Radiology

VAN DELLEN ASPIRATING TUBING

FDA 510(k)
FDA Class 2 ·General Hospital

IVT INTRODUCER SHEATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code MGB·February 22, 2013

RENAL-DISOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION - RENAL DIVISION·Product code FKX·January 31, 2011

S-ROM M HEAD 36MM +0

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 1, 2014

BD FACSCALIBUR FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 20, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026