17 results · 20ms · Sources: EU EUDAMED, US FDA

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F&P Airvo 3

FDA 510(k)
FDA Class 2 ·Anesthesiology

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025

BD BBL™ OF Medium with Xylose

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902213384·BD BBL™ OF Medium with Xylose

ZEOBI

FDA 510(k)
FDA Class 2 ·Physical Medicine

ACCULEAF

FDA 510(k)
FDA Class 2 ·Radiology

ARTISAN

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 21, 2024

UNKNOWN DEPUY PINNACLE ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 3, 2014

FLEXI-SEAL FMS ADVANCED ODOR CONTROL

FDA Adverse Event
Death ·CONVATEC·Product code KNT·August 17, 2011

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 1, 2013

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

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