Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

88 results for "Penumbra, Inc."
25–48 of 88
Search insights Median review: 89d Cleared: 100% Top manufacturer: Penumbra, Inc. Lead specialty: Neurology
Cleared May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
K203440 · NRY
Penumbra, Inc.
Neurology · 178d
Cleared Feb 26, 2021
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · QEW
Penumbra, Inc.
Cardiovascular · 22d
Cleared Feb 09, 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7,...
K210083 · QEW
Penumbra, Inc.
Cardiovascular · 28d
Cleared Nov 18, 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · QEW
Penumbra, Inc.
Cardiovascular · 55d
Cleared Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
K202251 · NRY
Penumbra, Inc.
Neurology · 21d
Cleared Aug 19, 2020
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
K193595 · QEW
Penumbra, Inc.
Cardiovascular · 240d
Cleared Jun 11, 2020
Benchmark BMX96 Access System
K201271 · DQY
Penumbra, Inc.
Neurology · 30d
Cleared May 28, 2020
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
K192981 · QEW
Penumbra, Inc.
Cardiovascular · 217d
Cleared CT Apr 22, 2020
Indigo Aspiration System Lightning Aspiration Tubing
K200771 · QEW
Penumbra, Inc.
Cardiovascular · 28d
Cleared CT Mar 13, 2020
Indigo Aspiration System – Lightning Aspiration Tubing
K193244 · QEW
Penumbra, Inc.
Cardiovascular · 109d
Cleared Feb 27, 2020
Penumbra System Penumbra JET 7X
K191946 · NRY
Penumbra, Inc.
Neurology · 220d
Cleared CT Dec 20, 2019
Indigo Aspiration System
K192833 · QEW
Penumbra, Inc.
Cardiovascular · 79d
Cleared Nov 20, 2019
Penumbra LP Coil System
K192955 · HCG
Penumbra, Inc.
Neurology · 30d
Cleared Aug 30, 2019
Artemis Eye System
K190719 · GWG
Penumbra, Inc.
Neurology · 163d
Cleared Jun 16, 2019
Penumbra System Reperfusion Catheter JET 7
K190010 · NRY
Penumbra, Inc.
Neurology · 164d
Cleared Apr 26, 2019
Penumbra System 3D Revascularization Device
K190464 · NRY
Penumbra, Inc.
Neurology · 59d
Cleared Mar 18, 2019
REAL Immersive System
K183296 · ISD
Penumbra, Inc.
Physical Medicine · 111d
Cleared Oct 12, 2018
Penumbra System (Modified 110 Aspiration Tubing)
K182522 · NRY
Penumbra, Inc.
Neurology · 29d
Cleared Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
K173761 · NRY
Penumbra, Inc.
Neurology · 249d
Cleared Jun 20, 2018
Penumbra System
K180008 · NRY
Penumbra, Inc.
Neurology · 169d
Cleared May 15, 2018
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and...
K180412 · QEW
Penumbra, Inc.
Cardiovascular · 89d
Cleared May 03, 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · QEW
Penumbra, Inc.
Cardiovascular · 23d
Cleared Apr 17, 2018
Penumbra Coil 400, Ruby Coil System, POD System
K173614 · HCG
Penumbra, Inc.
Neurology · 146d
Cleared Mar 08, 2018
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -...
K180105 · QEW
Penumbra, Inc.
Cardiovascular · 51d