FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15745–15768 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 19, 1983
NOVA BALLOON THERMODILUTION INFUSION
K832287 · DYG
Nova Medical Specialties
Cardiovascular · 98d
Cleared Oct 19, 1983
PERCLUDER DL OCCLUDING BALLOON
K832386 · DQO
Datascope Corp.
Cardiovascular · 92d
Cleared Oct 19, 1983
AXIOM PERFUSSION CANNULA
K832475 · DWF
Axiom Medical, Inc.
Cardiovascular · 85d
Cleared Oct 19, 1983
EPCOR MULTIELECTRODE TEMP. PERVENOUS
K832561 · LDF
Cordis Corp.
Cardiovascular · 79d
Cleared Oct 19, 1983
TOP THREE WAY STOPCOCK
K832625 · DTL
Top Surgical Manufacturers Co.
Cardiovascular · 76d
Cleared Oct 19, 1983
ELECATH PACEWEDGE DUAL PRESS. BIPOLAR
K832850 · LDF
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Oct 19, 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
K833098 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 18, 1983
LUNG POWER
K832195
Consolidated Medical Technologies
Cardiovascular · 103d
Cleared Oct 14, 1983
CARDIAC OUTPUT COMPUTER
K831407 · DXG
Ziehm International, Inc.
Cardiovascular · 165d
Cleared Oct 14, 1983
AS 1740 INTERFACE MODULE
K831428 · DRT
Narco Scientific
Cardiovascular · 164d
Cleared Oct 14, 1983
AS 191 ECG TELEMETRY MODULE
K831429 · DPS
Narco Scientific
Cardiovascular · 164d
Cleared Oct 14, 1983
PATIENT SELECTOR FUNCTION BLOCK
K832212 · DPS
Honeywell, Inc.
Cardiovascular · 100d
Cleared Oct 12, 1983
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
K831633 · DXY
Intermedics, Inc.
Cardiovascular · 145d
Cleared Oct 04, 1983
DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN
K831481 · DSK
Eugene Scarberry
Cardiovascular · 148d
Cleared Oct 04, 1983
SELF CHECK DIGITAL BLOOD PRESS. MONITOR
K832171 · DXN
Ritter Co.
Cardiovascular · 90d
Cleared Oct 04, 1983
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI
K832893 · DXY
Cook Pacemaker Corp.
Cardiovascular · 39d
Cleared Sep 29, 1983
BIOCHECK PEC-108 PROGRAM-PULSE MONITOR
K831752 · DRT
Biotechnology, Inc.
Cardiovascular · 120d
Cleared Sep 29, 1983
PATIENT MONITOR #78353A
K831787 · DRT
Hewlett-Packard Co.
Cardiovascular · 118d
Cleared Sep 29, 1983
CARDIO-SCOPE MINI MONITOR
K831878 · DPS
W.E. Leder Enterprises, Inc.
Cardiovascular · 108d
Cleared Sep 29, 1983
SHILEY MULTIPRO CATHETER
K832044 · DXE
Shiley, Inc.
Cardiovascular · 97d
Cleared Sep 29, 1983
FOGARTY-CHIN PERIPHERAL DILATION CATH
K832474 · LIT
American Edwards Laboratories
Cardiovascular · 65d