10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KELOCATE SHEETING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982051·posteriors; shade B2; size L; lower jaw
FUJIFILM Duodenoscope Model
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
FDA 510(k)
FDA Class 2
·Neurology
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·February 8, 2013
UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·February 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
OPTITORQUE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·Product code DQO·January 20, 2021
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024