12 results · 23ms · Sources: EU EUDAMED, US FDA

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Zoom 6F Insert Catheters

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·December 10, 2020

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·October 29, 2020

SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

MSA100 PEAK FLOW METER

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·September 29, 2020

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·December 7, 2020

TRIATHLON-CR FEMORAL COMPONENT CEMENTED #5 RIGHT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 31, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014

AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

FDA Adverse Event
Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·July 16, 2013

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·September 29, 2020

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024