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
13081–13104 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 23, 1989
PERIPHERAL ATHERECTOMY SYSTEM
K890515 · DWX
Intensive Technology, Inc.
Cardiovascular · 111d
Cleared May 23, 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · DRT
Healthdyne, Inc.
Cardiovascular · 56d
Cleared May 19, 1989
FORTEC MI-150 DIGITAL BLOOD PRESSURE METER
K884405 · DXN
Nam Tai Electronic & Electrical...
Cardiovascular · 211d
Cleared May 19, 1989
THE COACH
K884804 · DRT
Promark, Inc.
Cardiovascular · 183d
Cleared May 19, 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
K890206 · DQO
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
HIGH PRESSURE CONNECTING SETS
K890208 · DXT
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
DISPOSABLE ANGIOGRAPHY NEEDLES
K890209 · DRC
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
KENDALL SCD THERAPEUTIC SYSTEM
K890938 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 84d
Cleared May 19, 1989
MODIFIED EXTERNAL PAD
K891000 · DWS
Instromedix, Inc.
Cardiovascular · 81d
Cleared May 19, 1989
INTRODUCER FOR PTCA GUIDING CATHETERS
K891022 · DYB
Argon Medical Corp.
Cardiovascular · 80d
Cleared May 19, 1989
MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
K891230 · DTZ
Medtronic Blood Systems, Inc.
Cardiovascular · 73d
Cleared May 18, 1989
Q5000 PC WORKSTATION
K892113 · DQK
Quinton, Inc.
Cardiovascular · 66d
Cleared May 15, 1989
HARBORIN CENTRAL VENOUS CATHETER
K884628 · DQR
Harbor Medical Devices, Inc.
Cardiovascular · 189d
Cleared May 15, 1989
A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL
K885348 · DQO
Mallinckroot, Inc.
Cardiovascular · 138d
Cleared May 11, 1989
TYPE 9225 NIBP
K890005 · DXN
S & W Medico Teknik
Cardiovascular · 128d
Cleared May 11, 1989
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
K891148 · DSI
Del Mar Avionics
Cardiovascular · 69d
Cleared May 05, 1989
ACCUTHERM PTS-200
K890575 · DWJ
Medical Repackers Co.
Cardiovascular · 88d
Cleared May 02, 1989
SIEMENS SIRECUST 730 PATIENT MONITOR
K890791 · DPS
Siemens Medical Electronics
Cardiovascular · 74d
Cleared May 01, 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · DRX
S & W Medico Teknik
Cardiovascular · 153d
Cleared May 01, 1989
ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES
K885166 · DRO
Zmi Corp.
Cardiovascular · 139d
Cleared May 01, 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV
K890808 · DTZ
3M Company
Cardiovascular · 73d
Cleared May 01, 1989
MODIFIED STOCKERT-SHILEY VENOUS CATHETER
K890980 · DWF
Shiley, Inc.
Cardiovascular · 63d
Cleared Apr 26, 1989
TYPE 9040 SYSTEM ATHENA
K884116 · DPS
S & W Medico Teknik
Cardiovascular · 208d
Cleared Apr 26, 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · DRT
S & W Medico Teknik
Cardiovascular · 208d