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
17497–17520 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 12, 1978
DEFIBRILLATOR, MARK II
K781678 · LDD
Ipco Corp.
Cardiovascular · 71d
Cleared Dec 12, 1978
MONITOR/MINI SCOPE
K781679 · DPS
Ipco Corp.
Cardiovascular · 71d
Cleared Dec 11, 1978
PULSE GENERATOR, MODEL 240, EXTERNAL
K781327 · DTE
Intermedics, Inc.
Cardiovascular · 132d
Cleared Dec 08, 1978
PACING LEAD MODELS SA, 350, SAM 500
K781619 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD MODELS, MDM 1060, MDM 1090
K781620 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD MODELS, MAM 1260 MAM 1290
K781621 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD ADAPTER MODEL ACS 16
K781622 · DTD
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING MODELS MUM 860, MUM 890
K781623 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD MODEL MVM 860, MVM 890
K781625 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD ADAPTER, ACV 14, ACV 23
K781626 · DTD
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD ADAPTER MODEL ADB 21
K781627 · DTD
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 07, 1978
PACEMAKER, MODEL 229-01
K781738 · DXY
Intermedics, Inc.
Cardiovascular · 51d
Cleared Dec 06, 1978
GENERATOR, PULSE, SORIN MODEL DL-1
K780897 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 188d
Cleared Dec 05, 1978
MONITOR, NON-INVASIVE BLOOD PRESSURE
K782000 · DXN
Automated Screening Devices
Cardiovascular · 13d
Cleared Dec 04, 1978
TEMPORARY CARDIAC PACING WIRE
K781002 · LDF
Ethicon, Inc.
Cardiovascular · 172d
Cleared Dec 04, 1978
UNIPOPLAR ENDOCARDIAL LEADS
K781326 · DTB
American Technology, Inc.
Cardiovascular · 125d
Cleared Dec 04, 1978
OVALITH 10BP
K781377 · DXY
Coratomic, Inc.
Cardiovascular · 117d
Cleared Dec 04, 1978
ENDOCARDIAL BIPOLAR LEAD
K781456 · DTB
American Technology, Inc.
Cardiovascular · 103d
Cleared Dec 04, 1978
BLOOD PRESSURE, DIGITAL MODEL #2153
K781701 · DSK
Sears, Roebuck & Co.
Cardiovascular · 55d
Cleared Dec 04, 1978
PAD, COOLING #27-999
K781764 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 49d
Cleared Dec 04, 1978
TELEMETRY SYSTEM, BIOTEL 300
K781836 · DRG
Spacelabs, Inc.
Cardiovascular · 35d
Cleared Dec 04, 1978
ELECTRODES, IMPLANTABLE WITH ADAPTER
K781849 · DTB
Telectronics, Inc.
Cardiovascular · 38d
Cleared Dec 04, 1978
CHAMBER, MC-1 DISPOSABLE PRESSURE
K781890 · DXS
Delta Medical Industries
Cardiovascular · 28d
Cleared Dec 04, 1978
CARDIAC INSULATION PAD
K781990 · DWF
Shiley, Inc.
Cardiovascular · 7d