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
13009–13032 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 10, 1989
GENERAL SURGICAL INSTRUMENTS
K894670 · DXC
Nopa Instruments
Cardiovascular · 69d
Cleared Aug 09, 1989
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
K885179 · DYB
Baxter Healthcare Corp
Cardiovascular · 238d
Cleared Aug 09, 1989
USCI CORONARY INFUSION CATHETER
K891069 · DQY
C.R. Bard, Inc.
Cardiovascular · 161d
Cleared Aug 09, 1989
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY
K894430 · DYB
Daig Corp.
Cardiovascular · 23d
Cleared Aug 07, 1989
CARDIAC COMPUTATION SOFTWARE PACKAGE
K890636 · JOP
Elscint, Inc.
Cardiovascular · 180d
Cleared Aug 07, 1989
VOLUME COMPUTATION SOFTWARE PACKAGE
K890638 · JOP
Elscint, Inc.
Cardiovascular · 180d
Cleared Aug 03, 1989
BURRON TEFLON-COATED GUIDEWIRE
K884183 · DQX
Burron Medical, Inc.
Cardiovascular · 303d
Cleared Aug 03, 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580 · DQO
Boston Scientific Corp
Cardiovascular · 136d
Cleared Aug 03, 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · LDD
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Aug 03, 1989
PERCUTANEOUS INTRODUCER
K893658 · DYB
Medamicus, Inc.
Cardiovascular · 80d
Cleared Aug 03, 1989
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · DTL
3M Company
Cardiovascular · 79d
Cleared Aug 03, 1989
ASC-950 ECG AMPLIFIER
K894161 · DRR
Astro-Med, Inc.
Cardiovascular · 50d
Cleared Aug 03, 1989
SENSOCOR TM R-TEST 24OXL
K894234 · DXG
Sensocor
Cardiovascular · 44d
Cleared Aug 01, 1989
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
K893680 · DXE
Cathlab Corp.
Cardiovascular · 77d
Cleared Jul 28, 1989
DVM-4200 BLOOD FLOWMETER
K892707 · DPW
Koven and Assoc., Inc.
Cardiovascular · 105d
Cleared Jul 27, 1989
IMEX RHYTHM TEK
K890114 · DSH
Racom, Inc.
Cardiovascular · 197d
Cleared Jul 27, 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · DXH
Medtronic Vascular
Cardiovascular · 44d
Cleared Jul 24, 1989
ANGIOGRAPHY CUSTOM PACKS
K891572 · DTL
Procedure Packs, Inc.
Cardiovascular · 126d
Cleared Jul 20, 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410 · DXE
Baxter Healthcare Corp
Cardiovascular · 104d
Cleared Jul 19, 1989
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515
K892944 · JOP
Interspec, Inc.
Cardiovascular · 89d
Cleared Jul 14, 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · DSF
Datex Division Instrumentarium Corp.
Cardiovascular · 219d
Cleared Jul 14, 1989
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
K885175 · DTB
Possis Medical, Inc.
Cardiovascular · 212d
Cleared Jul 14, 1989
DISPOSABLE TRANSDUCER MANIFOLD
K890676 · DTL
L.O.N. Research, Inc.
Cardiovascular · 155d
Cleared Jul 14, 1989
SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02
K892446 · KRD
Shiley, Inc.
Cardiovascular · 95d