8 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

TNI softFlow 50

FDA 510(k)
FDA Class 2 ·Anesthesiology

All Poly Monotrial UC

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215081317·

PHILIPS INTELLIVUE TCG10

FDA 510(k)
FDA Class 2 ·Anesthesiology

QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 27, 2011

LYNX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

BIOCOR STENTED PORCINE HEART VALVE

FDA Adverse Event
Injury ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·September 26, 2008

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