10 results
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17ms
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Sources: EU EUDAMED, US FDA
3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M
FDA 510(k)
FDA Class 2
·General Hospital
Lifeshield
FDA UDI
ICU Medical, Inc.·10887787007791·LIFESHIELD LATEX-FREE Y-TYPE BLOOD SET WITH PUM...
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00887709044074·Cardia Catherization Economizer Spike Set with ...
ViewFinder Software Version 1.1
FDA 510(k)
FDA Class 2
·Radiology
LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOMET M2A HIP PROSTHESIS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·November 11, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·August 31, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021