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
12361–12384 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 15, 1991
CLOSED SYSTEM FLUSH SET
K904994 · DXT
Argon Medical Corp.
Cardiovascular · 69d
Cleared Jan 15, 1991
LAB-SITE
K905017 · DQO
Telos Medical Corp.
Cardiovascular · 69d
Cleared Jan 15, 1991
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · DQK
Hewlett-Packard Co.
Cardiovascular · 63d
Cleared Jan 15, 1991
DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.
K905311 · DWD
Baxter Bentley Laboratories, Inc.
Cardiovascular · 48d
Cleared Jan 15, 1991
DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS
K905312 · DWF
Baxter Bentley Laboratories, Inc.
Cardiovascular · 48d
Cleared Jan 11, 1991
MODEL 556 MONITOR
K905856 · DSF
Ge Medical Systems Information...
Cardiovascular · 88d
Cleared Jan 08, 1991
OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C
K903134 · DXN
Omron Marshall Products, Inc.
Cardiovascular · 175d
Cleared Jan 08, 1991
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
K903900 · DSK
Ppg Hellige B.V.
Cardiovascular · 138d
Cleared Jan 08, 1991
BIO-IMPEDANCE ANALYZER
K904109 · DSB
Xitron Technologies, Inc.
Cardiovascular · 124d
Cleared Jan 08, 1991
DYNAPULSE 200M
K904739 · DXN
Pulse Metric, Inc.
Cardiovascular · 82d
Cleared Jan 08, 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
K904741 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 82d
Cleared Jan 08, 1991
LOBOW
K905250 · LIT
Perinatal Systems
Cardiovascular · 48d
Cleared Jan 03, 1991
IVT INTRODUCER SHEATH
K903463 · DYB
Intensive Technology, Inc.
Cardiovascular · 155d
Cleared Jan 03, 1991
ATHANS EKG STANDARDIZER
K903671 · DPS
Advanced Medical Concepts, Inc.
Cardiovascular · 142d
Cleared Jan 03, 1991
MORSE BALLOON INFLATION DEVICE
K904275 · MAV
North American Instrument Corp.
Cardiovascular · 107d
Cleared Jan 03, 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602 · DXY
Medtronic Vascular
Cardiovascular · 85d
Cleared Jan 03, 1991
ACS URETHAN CORONARY GUIDING CATHETER
K904884 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 69d
Cleared Jan 03, 1991
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
K904941 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 63d
Cleared Dec 27, 1990
FIRST MEDIC MODEL 510
K896903 · LDD
Spacelabs, Inc.
Cardiovascular · 384d
Cleared Dec 27, 1990
CENTRAL VENOUS PRESSURE MANOMETER
K904674 · KRK
Medex, Inc.
Cardiovascular · 76d
Cleared Dec 27, 1990
THERATEK GROUP EXCHANGE CATHETER
K904680 · MCW
Dow Corning Wright
Cardiovascular · 73d
Cleared Dec 27, 1990
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147 · DXQ
Hewlett-Packard Co.
Cardiovascular · 42d
Cleared Dec 21, 1990
ARIES MELDICAL MODEL 2100HC HANK CRANK
K903925 · KFM
Aries Medical, Inc.
Cardiovascular · 130d
Cleared Dec 20, 1990
BODYHEAT
K902650 · DWJ
Medadvances, Inc.
Cardiovascular · 188d