FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
2041–2064 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 06, 2019
ID-Cap System
K183052 · OZW
Etectrx, Inc.
Cardiovascular · 399d
Cleared Dec 04, 2019
AIROS 6 Sequential Compression Device
K193069 · JOW
Airos Medical, Inc.
Cardiovascular · 30d
Cleared Dec 04, 2019
AIROS 8 Sequential Compression Device
K193068 · JOW
Airos Medical, Inc.
Cardiovascular · 30d
Cleared Dec 04, 2019
VenaPro Vascular Therapy System
K193020 · JOW
Innovamed Health, LLC
Cardiovascular · 35d
Cleared Dec 03, 2019
Glidesheath Slender Tibial Pedal Kit
K193160 · DYB
Terumo Medical Coporation
Cardiovascular · 18d
Cleared Dec 03, 2019
TriSalus Infusion System
K193107 · KRA
Trisalus Life Sciences
Cardiovascular · 25d
Cleared Nov 29, 2019
ASAHI CROSSWALK Peripheral Support Catheter
K192782 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Nov 27, 2019
Rhythmia HDxTM Mapping System
K192438 · DQK
Boston Scientific Corporation
Cardiovascular · 82d
Cleared Nov 27, 2019
Upper Arm Blood Pressure Monitor
K191673 · DXN
Famidoc Technology Company Limited
Cardiovascular · 156d
Cleared Nov 27, 2019
ECG Cable
K191428 · DSA
Shenzhen Changke Connect Electronics...
Cardiovascular · 182d
Cleared Nov 27, 2019
Hypotension Decision Assist
K190955 · DXG
Directed Systems, Ltd.
Cardiovascular · 230d
Cleared Nov 26, 2019
Advocate PTA Catheter
K192907 · LIT
Merit Medical Systems, Inc.
Cardiovascular · 42d
Cleared Nov 26, 2019
Heraeus Peripheral Guidewire
K191502 · DQX
Heraeus Medical Components, LLC
Cardiovascular · 173d
Cleared Nov 22, 2019
MatriStem UBM Pericardial Patch
K191734 · PSQ
Acell, Inc.
Cardiovascular · 147d
Cleared Nov 21, 2019
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
K192996 · DQY
Biotronik, Inc.
Cardiovascular · 24d
Cleared Nov 21, 2019
PG Pro Microcatheter
K192625 · DQY
MicroVention, Inc. A TERUMO Group...
Cardiovascular · 59d
Cleared Nov 21, 2019
Torpedo Gelatin Foam
K192480 · KRD
Biosphere Medical, S.A.
Cardiovascular · 72d
Cleared Nov 21, 2019
Asahi PTCA Guide Wire Asahi SION Series
K191464 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 171d
Cleared Nov 19, 2019
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550,...
K182979 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 389d
Cleared Nov 18, 2019
Impella CP Introducer
K192769 · DYB
Abiomed, Inc.
Cardiovascular · 49d
Cleared Nov 15, 2019
CAPERE Thrombectomy System
K192935 · QEW
Vascular Medcure, Inc.
Cardiovascular · 29d
Cleared Nov 14, 2019
Reprocessed ViewFlex™ Xtra ICE Catheter
K190478 · OWQ
Sterilmed, Inc.
Cardiovascular · 260d
Cleared Nov 12, 2019
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238 · DSP
Arrow International, Teleflex
Cardiovascular · 85d
Cleared Nov 08, 2019
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
K192019 · DQO
Abbott Medical
Cardiovascular · 102d