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GENVISC 850

FDA Adverse Event
Injury ·TEDEC-MEIJI FARMA·Product code MOZ·January 19, 2017

GENVISC 850

FDA Adverse Event
Injury ·TEDEC-MEIJI FARMA·Product code MOZ·January 24, 2017

GENVISC 850

FDA Adverse Event
Injury ·TEDEC-MEIJI FARMA·Product code MOZ·January 19, 2017

Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.

FDA Recall
Terminated ·Volcano Corporation·Product code OGX·November 3, 2010

On-X Life Technologies, Inc.

Manufacturer
🇺🇸 United States

Shanghai OGO Medical Instrument Co., Ltd

Manufacturer
🇨🇳 China

TiLite

FDA UDI
Tilite·00853316008075·

OGI, LLC

FDA registration
OGI, LLC·3 products·🇺🇸 United States

CGX, LLC

FDA registration
CGX, LLC·2 products·🇺🇸 United States

FGX Canada Corp

FDA registration
FGX Canada Corp·2 products·🇨🇦 Canada

FGX EUROPE Ltd

FDA registration
FGX EUROPE Ltd·2 products·🇬🇧 United Kingdom

DRILL GUIDE EXTENSION

FDA UDI
Biomet Orthopedics, LLC·00887868074950·

FGX International Limited - China

FDA registration
FGX International Limited - China·3 products·🇨🇳 China

Coalition AGX Plate and Coalition AGX Spacer

FDA 510(k)
FDA Class 2 ·Orthopedic

IMD 7GX

FDA 510(k)
FDA Class 1 ·Dental

GX Corporation Sdn. Bhd. (Specialty Plant)

Manufacturer
🇲🇾 Malaysia·1 Importer

AGX

FDA UDI
Widex A/S·05706069750164·Audigy AGXWU-IM (Light beige S-330 ) Left

AGX

FDA UDI
Widex A/S·05706069748734·Audigy AGXWU-FA (Midnight black S-440 ) Telecoi...

AGX

FDA UDI
Widex A/S·05706069669183·Audigy AGXWD-CIC (Light beige ) Left, RC coil, ...

AGX

FDA UDI
Widex A/S·05706069719659·Audigy AGXWU-IP (Dark brown ) Left