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