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."
49–72 of 88
Search insights Median review: 89d Cleared: 100% Top manufacturer: Penumbra, Inc. Lead specialty: Neurology
Cleared Aug 14, 2017
Artemis Neuro Evacuation Device
K171332 · GWG
Penumbra, Inc.
Neurology · 98d
Cleared Jul 19, 2017
POD Packing Coil
K170852 · HCG
Penumbra, Inc.
Neurology · 119d
Cleared May 24, 2017
INDIGO Aspiration System
K163618 · QEX
Penumbra, Inc.
Cardiovascular · 153d
Cleared CT Apr 20, 2017
Penumbra 3D Revascularization Device
K162901 · NRY
Penumbra, Inc.
Neurology · 185d
Cleared Sep 26, 2016
Penumbra Aspiration System
K161506 · QEW
Penumbra, Inc.
Cardiovascular · 117d
Cleared Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161640 · NRY
Penumbra, Inc.
Neurology · 28d
Cleared Jul 01, 2016
INDIGO Aspiration System
K161523 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Jun 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161064 · NRY
Penumbra, Inc.
Neurology · 58d
Cleared May 25, 2016
Penumbra System, Penumbra Pump MAX
K160449 · NRY
Penumbra, Inc.
Neurology · 97d
Cleared May 24, 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
K160533 · QEW
Penumbra, Inc.
Cardiovascular · 96d
Cleared Apr 20, 2016
Penumbra Smart Coil
K160832 · HCG
Penumbra, Inc.
Neurology · 26d
Cleared Mar 17, 2016
Apollo System
K152699 · GWG
Penumbra, Inc.
Neurology · 178d
Cleared Jan 13, 2016
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
K152541 · NRY
Penumbra, Inc.
Neurology · 131d
Cleared Dec 02, 2015
Lantern Delivery Microcatheter
K152840 · DQY
Penumbra, Inc.
Cardiovascular · 64d
Cleared Aug 06, 2015
Penumbra System 110 Aspiration Tubing
K151623 · NRY
Penumbra, Inc.
Neurology · 51d
Cleared Jul 10, 2015
Penumbra Smart Coil
K151572 · HCG
Penumbra, Inc.
Neurology · 29d
Cleared May 26, 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · QEW
Penumbra, Inc.
Cardiovascular · 237d
Cleared May 22, 2015
Penumbra System ACE
K142458 · NRY
Penumbra, Inc.
Neurology · 262d
Cleared Mar 18, 2015
Penumbra Smart Coil
K143218 · HCG
Penumbra, Inc.
Neurology · 128d
Cleared Jan 26, 2015
Benchmark Intracranial Access System
K142321 · DQY
Penumbra, Inc.
Cardiovascular · 160d
Cleared Jul 03, 2014
POD SYSTEM
K141134 · HCG
Penumbra, Inc.
Neurology · 63d
Cleared May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
K133317 · NRY
Penumbra, Inc.
Neurology · 197d
Cleared Jan 17, 2014
APOLLO SYSTEM
K132931 · GWG
Penumbra, Inc.
Neurology · 121d
Cleared Nov 20, 2012
PENUMBRA DDC CATHETERS
K122772 · DQY
Penumbra, Inc.
Cardiovascular · 71d