11 results · 23ms · Sources: EU EUDAMED, 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