9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GLUTAMINE-1-GLUTAMINE
FDA 510(k)
FDA Class 1
·Hematology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209110742·KIT, TCCC MODULE ONE - SKILLS; This kit contain...
ADVANCED TURBO DRIVE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ManipulatOR PRO, ManipulatOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 30, 2014
LINE SET FOR AQUARIUS
FDA Adverse Event
Malfunction
·HAEMOTRONICS SPA·Product code KDI·October 1, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900
FDA Enforcement
Class II
·Ongoing·North American Rescue LLC.·October 8, 2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900
FDA Recall
Open, Classified
·North American Rescue LLC.·Product code DXC·July 1, 2025