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
13129–13152 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 03, 1989
TRAUMAFUSE RAPID INFUSION DEVICE
K890077 · DTN
The Traumafuse Co.
Cardiovascular · 84d
Cleared Mar 31, 1989
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
K882507 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 287d
Cleared Mar 31, 1989
PHYSIOGARD SM 785
K885177 · DPS
Adam
Cardiovascular · 108d
Cleared Mar 31, 1989
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K890453 · DWZ
Dlp, Inc.
Cardiovascular · 60d
Cleared Mar 31, 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · DPS
Marquette Electronics, Inc.
Cardiovascular · 59d
Cleared Mar 28, 1989
VS-1 MODEL NUMBER 251K PULSE GENERATOR
K885267 · DXY
Pacesetter Systems
Cardiovascular · 96d
Cleared Mar 28, 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 28, 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 22, 1989
TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
K884866 · LDF
Oscor Medical Corp.
Cardiovascular · 121d
Cleared Mar 22, 1989
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
K890547 · DTB
Pacesetter Systems
Cardiovascular · 47d
Cleared Mar 22, 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · DRX
C.R. Bard, Inc.
Cardiovascular · 21d
Cleared Mar 20, 1989
10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC
K882274 · DSP
Kontron Instruments, Inc.
Cardiovascular · 293d
Cleared Mar 20, 1989
9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON
K882508 · DSP
Kontron Instruments, Inc.
Cardiovascular · 276d
Cleared Mar 16, 1989
506 NON-INVASIVE VITAL SIGNS MONITOR
K884216 · DSI
Criticare Systems, Inc.
Cardiovascular · 161d
Cleared Mar 16, 1989
ACS SELECTIVE INFUSION CATHETER
K885237 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Mar 15, 1989
ASTRO TRACE (MODEL AT-02)
K885137 · DSA
The LE Blanc Corp.
Cardiovascular · 90d
Cleared Mar 15, 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · DRX
Medtronic Vascular
Cardiovascular · 57d
Cleared Mar 15, 1989
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP
K890325 · LIT
C.R. Bard, Inc.
Cardiovascular · 51d
Cleared Mar 15, 1989
MEDILOG 9000-II AMBULATORY RECORDER
K890647 · DSH
Oxford Medilog, Inc.
Cardiovascular · 33d
Cleared Mar 10, 1989
VENA CAVA FILTER
K881604 · DTK
Vena-Tech, Inc.
Cardiovascular · 332d
Cleared Mar 10, 1989
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
K884981 · DRX
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 10, 1989
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982 · DRX
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 10, 1989
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · LIT
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Mar 10, 1989
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · DYB
Oscor Medical Corp.
Cardiovascular · 51d