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
13177–13200 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 23, 1989
LIFEPAK 10 DEFIBRILLATOR/MONITOR
K890079 · LDD
Physio-Control Corp.
Cardiovascular · 50d
Cleared Feb 23, 1989
CARDIOBEEPER IV
K890461 · DXH
Survival Technology, Inc.
Cardiovascular · 24d
Cleared Feb 22, 1989
SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
K884159 · DYB
Mallinckroot, Inc.
Cardiovascular · 141d
Cleared Feb 22, 1989
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · DQR
Daig Corp.
Cardiovascular · 120d
Cleared Feb 22, 1989
DAIG OBTURATOR, CATHETER INTRODUCER
K884494 · DYB
Daig Corp.
Cardiovascular · 120d
Cleared Feb 22, 1989
ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS
K884811 · DTB
Telectronics and Control Pacing Systems
Cardiovascular · 97d
Cleared Feb 22, 1989
INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
K885154 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 69d
Cleared Feb 13, 1989
FORCEPS-ORTHOPEDIC
K890165 · LXN
Dhason Brothers, Inc.
Cardiovascular · 35d
Cleared Feb 10, 1989
SURGI-CUF STERILE/NON-STERILE DISPOSABLE
K883977 · DXQ
Ethox Corp.
Cardiovascular · 143d
Cleared Feb 10, 1989
AFP MODEL 262T PULSE GENERATOR
K884733 · DXY
Pacesetter Systems
Cardiovascular · 92d
Cleared Feb 10, 1989
MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD
K885240 · DTB
Tpl-Cordis, Inc.
Cardiovascular · 51d
Cleared Feb 08, 1989
THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
K883412 · DWF
Promedica Products, Inc.
Cardiovascular · 177d
Cleared Feb 06, 1989
ARBO PINK H82P
K884775 · DRX
Arbo Medical, Inc.
Cardiovascular · 82d
Cleared Feb 06, 1989
MODEL 499 SSR ANALYSIS SYSTEM
K884887 · DSI
Del Mar Avionics
Cardiovascular · 76d
Cleared Feb 06, 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Feb 06, 1989
JEHLE CORONARY PERFUSION CATHETERS
K884946 · KRA
Pilling Co.
Cardiovascular · 70d
Cleared Feb 06, 1989
MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
K885188 · DWF
Quinton, Inc.
Cardiovascular · 61d
Cleared Feb 06, 1989
A10 ULTRASCOPE RECORDER
K890142 · DSF
Ems Medical, Inc.
Cardiovascular · 24d
Cleared Feb 03, 1989
RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER
K883845 · DXK
Phoenix Imaging
Cardiovascular · 144d
Cleared Feb 02, 1989
PACH-PEN CALCULATOR
K884619 · DXG
Oculab, Inc.
Cardiovascular · 90d
Cleared Feb 02, 1989
PATIENT MONITOR RIGEL MODEL MULTICARE 429
K884645 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 87d
Cleared Feb 02, 1989
PATIENT MONITOR MODEL 703
K884662 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 87d
Cleared Feb 02, 1989
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K884742 · DXN
Medical Data Electronics
Cardiovascular · 80d
Cleared Feb 02, 1989
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350 · DTB
Telectronics, Inc.
Cardiovascular · 86d