8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
FDA 510(k)
FDA Class 2
·General Hospital
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VERAVIEWEPOCS, MODEL VE
FDA 510(k)
FDA Class 2
·Dental
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code KNT·October 28, 2008
COMPOUNDERS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code NEP·August 17, 2011
IBGSTAR BGMS
FDA Adverse Event
Injury
·AGAMATRIX, INC.·Product code NBW·July 3, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024