9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
FDA 510(k)
FDA Class 2
·Cardiovascular
Dosimetry Check Version 5 Release 1
FDA 510(k)
FDA Class 2
·Radiology
LIBERTY CYCLER SET, SINGLE CONN. EXT. DL
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING·Product code FKX·June 30, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·February 14, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 7, 2011
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024