Penumbra, Inc

FDA Filings

This page includes the latest FDA filings for Penumbra, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Penumbra, Inc.
Penumbra LP Coil System2019-11-20
Penumbra, Inc.
Artemis Eye System2019-08-30
Penumbra, Inc.
Penumbra System Reperfusion Catheter JET 72019-06-16
Penumbra, Inc.
Penumbra System 3D Revascularization Device2019-04-26
Penumbra, Inc.
REAL Immersive System2019-03-18
Penumbra, Inc.
Penumbra System (Modified 110 Aspiration Tubing)2018-10-12
Penumbra, Inc.
Penumbra System Reperfusion Catheter JET 72018-08-17
Penumbra, Inc.
Penumbra System2018-06-20
Penumbra, Inc.
Indigo Aspiration System (CAT RX And Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX And Separator 4)- Penumbra Engine Pump Canister2018-05-15
Penumbra, Inc.
Indigo Aspiration System - Modified 110 Aspiration Tubing2018-05-03
Penumbra, Inc.
Penumbra Coil 400, Ruby Coil System, POD System2018-04-17
Penumbra, Inc.
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister2018-03-08
PENUMBRA, INC.
INDIGO Aspiration System2017-05-24
Penumbra, Inc.
Penumbra 3D Revascularization Device2017-04-20
Penumbra, Inc.
INDIGO Aspiration System2016-07-01
PENUMBRA, INC.
Penumbra Embolectomy Aspiration System [INDIGO System]2015-05-26
PENUMBRA, INC.
Penumbra System ACE2015-05-22
Penumbra, Inc.
Penumbra Smart Coil2015-03-18
PENUMBRA, INC.
APOLLO SYSTEM2014-01-17
PENUMBRA, INC.
PENUMBRA DDC CATHETERS2012-11-20
PENUMBRA, INC.
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING2012-10-02
PENUMBRA, INC.
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM2012-09-19
PENUMBRA, INC.
PENUMBRA SYSTEM MAX2011-11-23
PENUMBRA, INC.
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS0542009-09-21
PENUMBRA, INC.
PENUMBRA SYSTEM2007-12-28
PENUMBRA, INC.
PENUMBRA ASPIRATION PUMP, MODEL 115V2005-08-17

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Indigo System
PENUMBRA, INC.2019-02-04
Indigo System
PENUMBRA, INC.2019-02-04
Indigo
PENUMBRA, INC.2019-02-04
Indigo System
PENUMBRA, INC.2019-02-04
Indigo System
PENUMBRA, INC.2019-02-04
Indigo System
PENUMBRA, INC.2019-02-04
Indigo System
PENUMBRA, INC.2019-02-04
Indigo System
PENUMBRA, INC.2019-02-04

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