8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOVASCULAR REPAIR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
Implant Depth Probe
FDA UDI
STERNGOLD DENTAL LLC·00841549117725·Titanium
ANTI-RNP MICROASSAY
FDA 510(k)
FDA Class 2
·Immunology
KINAMED CEMENTED ATH-LONG STEM
FDA 510(k)
FDA Class 2
·Orthopedic
AFFINITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·January 9, 2013
UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 22, 2010
HEARTSTART XL + DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2014
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Enforcement
Class II
·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024