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Innova Vascular, Inc.

FDA registration
Innova Vascular, Inc.·2 products·🇺🇸 United States

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053004·One (1) Malibu Aspiration Catheter System: Mali...

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053011·One (1) Malibu Aspiration Catheter System: Mali...

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053028·One (1) Malibu Aspiration Catheter System: Mali...

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053035·One (1) Malibu Aspiration Catheter System: Mali...

Laguna Clot Retriever System

FDA UDI
Innova Vascular, Inc.·00850041053080·One (1) Laguna Clot Retriever System: Laguna Cl...

Laguna Clot Retriever System

FDA UDI
Innova Vascular, Inc.·00850041053110·One (1) Laguna Clot Retriever System: Laguna Cl...

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053042·One (1) Malibu Aspiration Catheter System: Mali...

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053073·One (1) Malibu Aspiration Catheter System: Mali...

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053059·One (1) Malibu Aspiration Catheter System: Mali...

Laguna Clot Retriever System

FDA UDI
Innova Vascular, Inc.·00850041053097·One (1) Laguna Clot Retriever System: Laguna Cl...

Laguna Clot Retriever System

FDA UDI
Innova Vascular, Inc.·00850041053103·One (1) Laguna Clot Retriever System: Laguna Cl...

Malibu Aspiration Catheter System

FDA UDI
Innova Vascular, Inc.·00850041053066·One (1) Malibu Aspiration Catheter System: Mali...

PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

FDA Adverse Event
Malfunction ·COVIDIEN·Product code FGE·June 24, 2016

PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

FDA Adverse Event
Injury ·COVIDIEN·Product code FGE·June 24, 2016

GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

FDA Recall
Terminated ·Datex Ohmeda, Inc·Product code MQB·August 17, 2006

GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

FDA Recall
Terminated ·Datex Ohmeda, Inc·Product code MQB·August 17, 2006

GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

FDA Recall
Terminated ·Datex Ohmeda, Inc·Product code MQB·August 17, 2006