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Penumbra, Inc.

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall (Z-2770-2026)Penumbra, Inc.2026-07-21
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter w recall (Z-0848-2021)Penumbra Inc.2021-01-18
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT recall (Z-0849-2021)Penumbra Inc.2021-01-18
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L13 recall (Z-0850-2021)Penumbra Inc.2021-01-18
Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow A recall (Z-0851-2021)Penumbra Inc.2021-01-18
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of recall (Z-2702-2017)Penumbra Inc.2017-06-22
Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distri recall (Z-1906-2011)Penumbra Inc.2011-04-12
Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, ma recall (Z-0428-2011)Penumbra Inc.2010-11-24
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058 recall (Z-0001-2010)Penumbra Inc.2009-10-05
Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., A recall (Z-2313-2009)Penumbra Inc.2009-09-24
Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, man recall (Z-2049-2009)Penumbra Inc.2009-09-08

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Every clearance here is in the API, with alerts when new ones post.