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Results for “P130”
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EUDAMED
27
FDA 510(k)
3
FDA PMA
GUDID
82
Country / market
European Union (all)
27
United States
85
More countries (4)
France
24
Spain
1
Italy
1
Slovakia
1
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Class I
21
Class IIa
1
Class IIb
Class III
24
Class II (US)
66
More classes (11)
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IVD Annex II List A
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60 devices found
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Device · Manufacturer · Authorizations
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Status
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Registry
Class
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
Stryker Leibinger GmbH & Co. KG
·
,
Germany
Class III
FDA PMA
P130014
Active
Approved 30 Mar 2015
Active
PMA
PMA
III
Solo Smart Heart Valve
Corcym Canada Corp
·
,
FDA registration: Canada
Class III
FDA PMA
P130011
Withdrawn
Approved 24 Jun 2014
Withdrawn
PMA
, withdrawn
PMA
III
Cologuard
Exact Sciences Corporation
·
,
United States
Class III
FDA PMA
P130017
Active
Approved 11 Aug 2014
Active
PMA
PMA
III
Animas Vibe System
Animas Corp.
·
,
United States
(FDA 510(k) applicant)
Class III
FDA PMA
P130007
Withdrawn
Approved 25 Nov 2014
Withdrawn
PMA
, withdrawn
PMA
III
Artus Cmv Rgq Mdx Kit
Qiagen, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA PMA
P130027
Active
Approved 2 Jun 2014
Active
PMA
PMA
II
Fluency Plus Endovascular Stent Graft
Bard Peripheral Vascular, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
FDA PMA
P130029
Active
Approved 17 Jun 2014
Active
PMA
PMA
III
Rebel Platinum Chromium Coronary Stent System (Monorail And Over The Wire)
Boston Scientific
·
,
United States
Class III
FDA PMA
P130030
Active
Approved 4 Aug 2014
Active
PMA
PMA
III
WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
Boston Scientific
·
,
United States
Class III
FDA PMA
P130013
Active
Approved 13 Mar 2015
Active
PMA
PMA
III
Myopore Sutureless Myocardial Pacing Lead
Great Batch Medical
·
,
United States
Class III
FDA PMA
P130012
Active
Approved 30 Apr 2015
Active
PMA
PMA
III
Tacticath Quartz Ablation Catheter
Open recall
St Jude Medical
·
,
FDA registration: United States
Class III
FDA PMA
P130026
Active
Approved 24 Oct 2014
Active
PMA
PMA
III
Algovita Spinal Cord Stimulation System
Nuvectra Corporation
·
,
FDA registration: United States
Class III
FDA PMA
P130028
Active
Approved 20 Nov 2015
Active
PMA
PMA
III
Diamondback 360 Coronary Orbital Atherectomy Device (Oad), Orbital Atherectomy System Pump (Oas Pump), Viperwire Advance
Cardiovascular Systems, Inc.
·
,
United States
Class III
FDA PMA
P130005
Active
Approved 21 Oct 2013
Active
PMA
PMA
III
Koning Breast CT, KBCT
Koning Corporation
·
,
FDA registration: United States
Class III
FDA PMA
P130025
Active
Approved 14 Jan 2015
Active
PMA
PMA
III
Gore Viabahn Endoprosthesis With Heparin Bioactive Surface
W. L. Gore & Associates, Inc.
·
,
United States
Class III
FDA PMA
P130006
Active
Approved 5 Dec 2013
Active
PMA
PMA
III
Drug Coated Balloon (Dcb)
Lutonix
·
,
FDA registration: United States
Class III
FDA PMA
P130024
Active
Approved 9 Oct 2014
Active
PMA
PMA
III
Medtronic CoreValve System
Medtronic, Inc.
·
,
United States
Class III
FDA PMA
P130021
Active
Approved 17 Jan 2014
Active
PMA
PMA
III
Senza Spinal Cord Stimulation (SCS) Systems
Nevro Corporation
·
,
FDA registration: United States
Class III
FDA PMA
P130022
Active
Approved 8 May 2015
Active
PMA
PMA
III
Model 2740 Inspire Programmer System
Open recall
Inspire Medical Systems
·
,
FDA registration: United States
Class III
FDA PMA
P130008
Active
Approved 30 Apr 2014
Active
PMA
PMA
III
SAPIEN XT Transcatheter Heart Valve
Edwards Lifesciences LLC
·
,
United States
Class III
FDA PMA
P130009
Active
Approved 16 Jun 2014
Active
PMA
PMA
III
Elecsys HBeAg and PreciControl HBeAg
Roche Diagnostics Operations, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA PMA
P130015
Active
Approved 14 Mar 2014
Active
PMA
PMA
II
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