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

Filters: Cardiovascular ×
18,182 results
2113–2136 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared CT 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