8 results · 18ms · Sources: EU EUDAMED, US FDA

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20GA X 7-1/2 THREADING BULLET POINT NEEDLE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

FDA 510(k)
FDA Class 2 ·Immunology

ELECTRA AUTOMATIC SAMPLER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BIVONA

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·January 5, 2021

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·June 25, 2014

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·November 10, 2010

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 20, 2012

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