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
14569–14592 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 26, 1986
MEDILOG 4500 SYSTEM
K860079 · DSI
Oxford Medilog, Inc.
Cardiovascular · 49d
Cleared Feb 26, 1986
MODEL MR-30 HOLTER RECORDER
K860181 · DSH
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1986
MODEL MR-35 HOLTER RECORDER
K860182 · DSH
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Feb 24, 1986
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K853101 · DSY
Cobe Laboratories, Inc.
Cardiovascular · 216d
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK
K853400 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 199d
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA
K853471 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 189d
Cleared Feb 24, 1986
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
K860202 · DXY
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Feb 24, 1986
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
K860466 · DXY
Cook Pacemaker Corp.
Cardiovascular · 18d
Cleared Feb 21, 1986
MERIDIAN ULTRASOUND IMAGING SYSTEM
K853240 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 204d
Cleared Feb 21, 1986
CPRCOACH VOICE PROMPTER & CPR PROMPTER RESCUE AID
K860555
Auralogic
Cardiovascular · 7d
Cleared Feb 20, 1986
SONOLAYER S, SSH-65A
K854606 · DXK
Toshiba Medical Systems
Cardiovascular · 94d
Cleared Feb 18, 1986
ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
K850861 · DXT
Medical Components, Inc.
Cardiovascular · 354d
Cleared Feb 18, 1986
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
K855089 · DQX
Dlp, Inc.
Cardiovascular · 60d
Cleared Feb 18, 1986
CIRIBART GYUDUBG CATGETER
K855103 · DQO
Mansfield Scientific, Inc.
Cardiovascular · 57d
Cleared Feb 14, 1986
NI-PACER 1
K854853 · DRO
Associated Medical Devices, Inc.
Cardiovascular · 71d
Cleared Feb 12, 1986
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
K854997 · DTD
Telectronics, Inc.
Cardiovascular · 62d
Cleared Feb 12, 1986
SWELL-RELIEF
K855004 · DRM
D.A. Schulman, Inc.
Cardiovascular · 61d
Cleared Feb 12, 1986
PDS 9000 PATIENT DATA MGMT. SYSTEM
K855055 · DQK
Marquette Electronics, Inc.
Cardiovascular · 56d
Cleared Feb 12, 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared Feb 10, 1986
VENOUS RETURN CANNULA W/CUFF 91039
K854487 · DWF
Dlp, Inc.
Cardiovascular · 94d
Cleared Feb 10, 1986
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
K854511 · DQX
Electro-Catheter Corp.
Cardiovascular · 90d
Cleared Feb 10, 1986
MODIFIED CORONARY CARDIOPLEGIA ADAPTOR
K854640 · DWF
Shiley, Inc.
Cardiovascular · 83d
Cleared Feb 10, 1986
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
K854734 · DRM
Medasonics, Inc.
Cardiovascular · 77d
Cleared Feb 10, 1986
SHILEY VENOUS RESERVOIR
K854841 · DTN
Shiley, Inc.
Cardiovascular · 68d