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

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H-H HUNTER PASSIVE TENDON IMPLANT

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

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209119523·KIT, RTF CHEST POUCH - COY - CUSTOM

LATERAL Spine Truss System

FDA 510(k)
FDA Class 2 ·Orthopedic

SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

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

PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 4, 2014

8MM MCS TIP COVER ACCESSORY

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 30, 2012

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 28, 2010

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

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