11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oscar Peripheral Multifunctional Catheter system
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIAL RING D.56
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489417115·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312417110·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322417110·
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
FDA 510(k)
FDA Class 2
·Orthopedic
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROFORM 3 STENT SYSTEM
FDA Adverse Event
Injury
·NEUROVASCULAR DIVISON, BOSTON SCIENTIFIC CORPORATION·Product code NJE·November 20, 2008
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 22, 2013
PROTEK DUO VENO-VENOUS CANNULA
FDA Adverse Event
Death
·CARDIACASSIST INC.·Product code DWF·December 11, 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