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
6409–6432 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 20, 2007
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
K073230 · DTA
Biotronik, Inc.
Cardiovascular · 35d
Cleared Dec 20, 2007
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
K072697 · DTN
3t Medical Systems, LLC
Cardiovascular · 87d
Cleared Dec 20, 2007
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
K071885 · OED
Philips Medical Systems
Cardiovascular · 164d
Cleared Dec 20, 2007
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K071818 · DQK
St Jude Medical
Cardiovascular · 170d
Cleared Dec 20, 2007
STUDIODOP VICORDER
K071730 · JOP
Skidmore Medical, Limited
Cardiovascular · 178d
Cleared Dec 19, 2007
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
K072810 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 79d
Cleared Dec 19, 2007
DUAL SHOT ALPHA
K071691 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 182d
Cleared Dec 18, 2007
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065,...
K072796 · DQO
Concentric Medical, Inc.
Cardiovascular · 78d
Cleared Dec 18, 2007
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K071995 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 151d
Cleared Dec 18, 2007
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · DXQ
Welch Allyn, Inc.
Cardiovascular · 347d
Cleared Dec 14, 2007
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 95d
Cleared Dec 13, 2007
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
K070225 · DSP
Abiomed, Inc.
Cardiovascular · 323d
Cleared Dec 12, 2007
PASSEO 18
K072765 · LIT
Biotronik, Inc.
Cardiovascular · 75d
Cleared Dec 07, 2007
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
K073372 · DXJ
Systemsone
Cardiovascular · 4d
Cleared Dec 07, 2007
THE CROSSER SYSTEM
K072776 · PDU
Flowcardia, Inc.
Cardiovascular · 70d
Cleared Dec 07, 2007
DM-EMG
K072513 · DWJ
Gvp Elettronica Srl
Cardiovascular · 92d
Cleared Dec 07, 2007
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB
K072137 · DXN
Avita Corporation
Cardiovascular · 127d
Cleared Dec 07, 2007
LIFE+CEL BATTERY
K071164 · MHX
Amco International Manufacturing &...
Cardiovascular · 225d
Cleared Dec 05, 2007
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
K072558 · QYX
Cardionet, Inc.
Cardiovascular · 85d
Cleared Dec 04, 2007
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
K072750 · DQY
Spectranetics Corp.
Cardiovascular · 68d
Cleared Dec 03, 2007
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
K073147 · MXC
Transoma Medical
Cardiovascular · 25d
Cleared Nov 30, 2007
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
K073100 · DYB
Oscor, Inc.
Cardiovascular · 28d
Cleared Nov 29, 2007
SA-3000P
K073323 · JOM
Medicore Co., Ltd.
Cardiovascular · 2d
Cleared Nov 29, 2007
CARESCAPE V100
K073203 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d