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
13657–13680 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 05, 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815 · DQO
Target Therapeutics
Cardiovascular · 77d
Cleared Feb 05, 1988
POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS
K874852 · DWF
Polystan C/O Vitalcor, Inc.
Cardiovascular · 72d
Cleared Feb 05, 1988
POLYSTAN TWO STAGE CATHETERS
K874853 · DWF
Polystan C/O Vitalcor, Inc.
Cardiovascular · 72d
Cleared Feb 05, 1988
LAWRENCE L3000 CARDIAC OUTPUT MONITOR
K874885 · DPW
Lawrence Medical Systems, Inc.
Cardiovascular · 66d
Cleared Feb 05, 1988
CARDIOVASCULAR SURGICAL INSTRUMENTS
K874960 · DWS
Solway, Inc.
Cardiovascular · 65d
Cleared Feb 05, 1988
NEW MODEL MB-550 BLOOD PRESSURE MONITOR
K875093 · DXN
Sharp Electronics Corp.
Cardiovascular · 57d
Cleared Feb 04, 1988
A-V RECORDER
K873041 · DPT
Life Sciences Manufacturing, Inc.
Cardiovascular · 184d
Cleared Feb 02, 1988
PTI HEART-CHILL POUCH/PAD SLING (STERILE)
K873924 · DWC
Buckman Co., Inc.
Cardiovascular · 130d
Cleared Feb 02, 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962 · DTB
Medtronic Vascular
Cardiovascular · 126d
Cleared Feb 02, 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
K874205 · DTB
Pacesetter Systems
Cardiovascular · 110d
Cleared Feb 02, 1988
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605 · KRI
Mallinckrodt Critical Care
Cardiovascular · 85d
Cleared Feb 02, 1988
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
K874841 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 02, 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · DWF
3M Health Care, Sarns
Cardiovascular · 63d
Cleared Feb 02, 1988
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939 · DXQ
Kirschner Medical Corp.
Cardiovascular · 62d
Cleared Jan 29, 1988
SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE
K873533 · DSI
Medical Electronics Laboratories, Inc.
Cardiovascular · 150d
Cleared Jan 29, 1988
VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM
K873546 · DWJ
Reimers Engineering, Inc.
Cardiovascular · 150d
Cleared Jan 29, 1988
ANGIO WASTE FLUIDS DUMP BAG
K874037 · DQO
Procedure Products, Inc.
Cardiovascular · 116d
Cleared Jan 29, 1988
ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD
K874183 · DTB
Daig Corp.
Cardiovascular · 108d
Cleared Jan 29, 1988
MODIFIED MYOCARDIAL TEMPERATURE SENSOR
K874522 · KRB
Mon-A-Therm, Inc.
Cardiovascular · 88d
Cleared Jan 29, 1988
PATIENTWATCH (TM)
K874571 · DSH
Advanced Medical Technology, Inc.
Cardiovascular · 85d
Cleared Jan 29, 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · DRT
Healthdyne, Inc.
Cardiovascular · 74d
Cleared Jan 29, 1988
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
K874927 · DWC
Pioneering Technologies, Inc.
Cardiovascular · 58d
Cleared Jan 28, 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)
K872866 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 191d
Cleared Jan 28, 1988
450SLL DEFIBRILLATOR
K874204 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 105d