12 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780383468·Integra® Jarit® Bruns Oval Cup Curette, 9", Sol...
MICROVASCULAR ANASTOMOTIC DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KOALA TOCO
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2013
OT ULTRA MINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·March 19, 2021
OT ULTRA MINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·March 19, 2021
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
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