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
9817–9840 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 10, 1998
TEMPORARY CARDIAC PACING WIRE
K980503 · LDF
Ethicon, Inc.
Cardiovascular · 60d
Cleared Apr 08, 1998
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K963703 · DPT
International Biophysics Corp.
Cardiovascular · 569d
Cleared Apr 08, 1998
BETTER-TUBING
K964205 · DWF
Circulatory Technology, Inc.
Cardiovascular · 537d
Cleared Apr 06, 1998
MANAN POTTS-COURNAND NEEDLE
K974742 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN
K974743 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN GWI GUIDE WIRE INTRODUCER
K974745 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 03, 1998
OZ POWER SYRINGE
K973334 · DXT
Cardiovascular Innovations
Cardiovascular · 211d
Cleared Apr 01, 1998
BIPORE BALLOON DILATATION CATHETER
K973563 · LIT
Bipore, Inc.
Cardiovascular · 194d
Cleared Apr 01, 1998
BIOLOG 3000 ELECTROCARDIOGRAPH
K974351 · DPS
Micromedical, Inc.
Cardiovascular · 133d
Cleared Mar 31, 1998
CHASE FEMORAL ACCESS CANNULATION SET
K972993 · DWF
Chase Medical, Inc.
Cardiovascular · 231d
Cleared Mar 31, 1998
CARDIO-PAGER SYSTEM
K973527 · MSX
Data Critical Corp.
Cardiovascular · 194d
Cleared Mar 25, 1998
AFFINITY MEDICAL PATIENT CABLE SYSTEM
K980806 · DSA
Affinity Medical Technologies, LLC
Cardiovascular · 22d
Cleared Mar 23, 1998
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
K971910 · DSI
Hewlett-Packard GmbH
Cardiovascular · 304d
Cleared Mar 20, 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
K980119 · DQX
Guidant Corp.
Cardiovascular · 66d
Cleared Mar 19, 1998
A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
K980824 · DXN
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Mar 18, 1998
BIOZ.COM SYSTEM
K974725 · DSB
Cardiodynamics International Corp.
Cardiovascular · 90d
Cleared Mar 18, 1998
M1765A ECG MANAGER
K974746 · DPS
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Mar 17, 1998
DCAT EMBOLECTOMY CATHETER SYSTEM
K971314 · DXE
AngioDynamics, Inc.
Cardiovascular · 342d
Cleared Mar 16, 1998
ZOLL REVIVER
K972241 · MKJ
Zoll Medical Corp
Cardiovascular · 273d
Cleared Mar 16, 1998
MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
K980582 · DSA
Marquette Medical Systems, Inc.
Cardiovascular · 27d
Cleared Mar 13, 1998
MS-700
K972213 · DPW
Alan S. Lee
Cardiovascular · 274d
Cleared Mar 13, 1998
CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)
K973061 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 207d
Cleared Mar 13, 1998
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL...
K973474 · MHX
Witt Biomedical Corporation
Cardiovascular · 182d
Cleared Mar 13, 1998
COAXIAL DILATOR SET
K974640 · DRE
Boston Scientific Corp
Cardiovascular · 88d