FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

87 results for "Penumbra, Inc."

73–87 of 87

Search insights Median review: 94d Cleared: 100% Top manufacturer: Penumbra, Inc. Lead specialty: Neurology

Cleared Sep 19, 2012

PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM

Cardiovascular · 79d

Cleared Apr 02, 2012

PENUMBRA COIL SYSTEM/PENUMBRA COIL 400

Neurology · 60d

Cleared Nov 23, 2011

PENUMBRA SYSTEM MAX

Neurology · 28d

Cleared Jul 19, 2011

NEURON MAX SYSTEM

Cardiovascular · 64d

Cleared Jan 26, 2011

PENUMBRA EMBOLIZATION COIL SYSTEM

Neurology · 78d

Cleared Jul 13, 2010

PENUMBRA CATHERER 025

Cardiovascular · 111d

Cleared May 21, 2010

PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032,...

Neurology · 64d

Cleared Jan 15, 2010

Cardiovascular · 23d

Cleared Sep 21, 2009

PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054

Neurology · 185d

Cleared Nov 21, 2008

NEURON SELECT CATHETER SIZE 070

Cardiovascular · 30d

Cleared Oct 31, 2008

NEURON DELIVERY CATHETER 070

Cardiovascular · 81d

Cleared Dec 28, 2007

PENUMBRA SYSTEM

Neurology · 94d

Cleared Aug 17, 2007

NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F

Cardiovascular · 133d

Cleared Apr 27, 2006

PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F

Cardiovascular · 133d

Cleared Aug 17, 2005

PENUMBRA ASPIRATION PUMP, MODEL 115V

General & Plastic Surgery · 49d