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
16009–16032 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 14, 1983
SWITCHING UNIT ELECTRODE CATHETERS
K823361 · DRF
Webster Laboratories, Inc.
Cardiovascular · 66d
Cleared Jan 14, 1983
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
K823451 · DTR
3M Health Care, Sarns
Cardiovascular · 58d
Cleared Jan 14, 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508 · DTB
Intermedics, Inc.
Cardiovascular · 49d
Cleared Jan 12, 1983
GORE-TES EXPANDED PTFE PATCH
K821717 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 216d
Cleared Jan 08, 1983
ELECTRODE LEAD OF SILICONE ELASTOMETER
K823452 · DTB
Telectronics, Inc.
Cardiovascular · 52d
Cleared Jan 05, 1983
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
K823273 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 64d
Cleared Jan 05, 1983
OXYGEN CONSUMPTION MONITOR #OCM-0100
K823359 · DRY
Bentley Laboratories, Inc.
Cardiovascular · 61d
Cleared Jan 05, 1983
CARDF
K823731 · DTP
Shiley, Inc.
Cardiovascular · 26d
Cleared Dec 30, 1982
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · DSH
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
K823033 · DTB
Pacesetter Systems
Cardiovascular · 77d
Cleared Dec 30, 1982
BACKSTOP VALVE W/SIDE ARM
K823190 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
DISPOSABLE PLASTIC STOPCOCK
K823191 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
TUOHY-BORST ADAPTER W/SIDE ARM
K823192 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
MODEL 8300 TESTER
K823197 · DRT
Medicon, Inc.
Cardiovascular · 65d
Cleared Dec 30, 1982
INJECTION FILL TUBE
K823238 · DXT
Vetrex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
VERTEX MONITORING CATHETER
K823253 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
REUSABLE METAL STOPCOCK
K823254 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
K823256 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
VENOUS RESERVOIR BAG #BMR-1400
K823272 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 58d
Cleared Dec 30, 1982
MODELS DPT 1000/DPT 1000NS
K823286 · DRS
Bio-Med Corp.
Cardiovascular · 56d
Cleared Dec 30, 1982
NEUROMEDICS PACETRON HEART RATE MONITOR
K823290 · DRT
Intermedics, Inc.
Cardiovascular · 55d
Cleared Dec 30, 1982
CLEAR VINYL MONITORING CONNECTOR
K823340 · DXT
Vertex Medical Corp.
Cardiovascular · 52d
Cleared Dec 30, 1982
HOLTER KIT MODEL #5000 SERIES
K823414 · DSH
Andover Medical, Inc.
Cardiovascular · 45d
Cleared Dec 30, 1982
MON-A-THERM MYOCARDIAL TEMP. SENSOR
K823435 · KRB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 44d