9 results
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24ms
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Sources: EU EUDAMED, US FDA
MAGNETO EYEWEAR
FDA 510(k)
FDA Class 1
·Ophthalmic
Calibration gas 1
FDA UDI
Radiometer Medical ApS·05700699621696·Calibration gas 1, 10bar on-board gas bottle
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156012·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 230mm
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EdgeOne CO2 Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 14, 2013
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 28, 2014
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·January 17, 2011
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026