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
12241–12264 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 09, 1991
VARIOUS TYPES OF STETHOSCOPES
K905487 · LDE
Liaoning-Usa Corp.
Cardiovascular · 124d
Cleared Apr 09, 1991
MODEL 5866-46 SLEEVE KIT
K910568 · DTP
Medtronic Vascular
Cardiovascular · 57d
Cleared Apr 09, 1991
BCD ADVANCED
K910923 · DTR
Shiley, Inc.
Cardiovascular · 35d
Cleared Apr 09, 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · LIT
Boston Scientific Corp
Cardiovascular · 39d
Cleared Apr 09, 1991
OPTI-PLAST 5F PTA CATHETERS
K910996 · LIT
Vas-Cath, Inc.
Cardiovascular · 36d
Cleared Apr 09, 1991
TEGWIRE (TM)
K911203 · LIT
Boston Scientific Corp
Cardiovascular · 21d
Cleared Apr 03, 1991
VENAPULSE MODELS VP-25 AND VP-50
K903894 · JOW
Aci Medical, Inc.
Cardiovascular · 223d
Cleared Apr 02, 1991
CONDOR ANALOG INFLATION SYRINGE
K904508 · MAV
Professional Medical Services
Cardiovascular · 180d
Cleared Apr 02, 1991
OCHSNER 500 VASCULAR PROSTHESIS
K905269 · DSY
Intervascular, Inc.
Cardiovascular · 130d
Cleared Apr 01, 1991
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · DYB
Cordis Corp.
Cardiovascular · 182d
Cleared Apr 01, 1991
E-Z-EM PULSED INFUSION SYSTEM
K905447 · KRA
E-Z-Em, Inc.
Cardiovascular · 117d
Cleared Apr 01, 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · DQO
Baxter Healthcare Corp
Cardiovascular · 75d
Cleared Apr 01, 1991
KELLER VITAL SIGNS MONITOR - KMS-890
K910262 · DSJ
Keller Medical Specialties Products,...
Cardiovascular · 69d
Cleared Apr 01, 1991
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K910863 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
K910864 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
K910865 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
K910866 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Mar 29, 1991
FLOWIRE AND FLOMAP
K905411 · DPW
Cardio Metrics, Inc.
Cardiovascular · 116d
Cleared Mar 29, 1991
ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH
K905831 · DRF
Arzco Medical Electronics, Inc.
Cardiovascular · 88d
Cleared Mar 26, 1991
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
K910464 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 50d
Cleared Mar 25, 1991
OWENS CATHETER
K896520 · LIT
Boston Scientific Corp
Cardiovascular · 495d
Cleared Mar 25, 1991
DYNAMIC SPECTRAL PHONOCARDIOGRAPH
K902185 · DQC
Reeves Scientific, Inc.
Cardiovascular · 315d
Cleared Mar 25, 1991
DIAGNOSTIC INTRASCULAR CATHETER
K903848 · DQO
Applied Vascular Devices, Inc.
Cardiovascular · 216d
Cleared Mar 25, 1991
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)
K904410 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 180d