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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
11545–11568 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 03, 1993
PERIFLUX PF4001 LASER DOPPLER FLOWMETER
K922368 · DPW
Perimed, Inc.
Cardiovascular · 259d
Cleared Feb 03, 1993
CORDIS VIERA GUIDEWIRE
K923696 · DQX
Cordis Corp.
Cardiovascular · 195d
Cleared Feb 02, 1993
STOCKERT 1/4 BUBBLE SENSOR
K925541 · KRL
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 91d
Cleared Jan 29, 1993
MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW
K922669 · DPW
Koven and Assoc., Inc.
Cardiovascular · 239d
Cleared Jan 28, 1993
CARDIOBEEPER(R) CB-IIA
K925535 · DXH
Survival Technology, Inc.
Cardiovascular · 87d
Cleared Jan 26, 1993
RESPONSE(TM) STEERABLE CATHETER
K913940 · DRA
Daig Corp.
Cardiovascular · 511d
Cleared Jan 22, 1993
SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K920333 · DPW
Koven and Assoc., Inc.
Cardiovascular · 361d
Cleared Jan 22, 1993
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K920822 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 333d
Cleared Jan 22, 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972 · DTB
Intermedics, Inc.
Cardiovascular · 217d
Cleared Jan 22, 1993
PHONOCARDIOGRAPH
K924054 · DQC
Echo Ultrasound
Cardiovascular · 163d
Cleared Jan 22, 1993
PASSAGE HEMOSTASIS VALVE
K925419 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 87d
Cleared Jan 21, 1993
EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI
K923681 · DYB
Exonix Research Corp.
Cardiovascular · 183d
Cleared Jan 21, 1993
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116 · DXT
Medrad, Inc.
Cardiovascular · 160d
Cleared Jan 15, 1993
PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS
K920587 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 340d
Cleared Jan 14, 1993
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K920873 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 324d
Cleared Jan 13, 1993
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
K920869 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 323d
Cleared Jan 13, 1993
INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM
K922970 · MCW
Intensive Technology, Inc.
Cardiovascular · 208d
Cleared Jan 13, 1993
DISPOSABLE VASCULAR ANGIOSCOPE
K923996 · LYK
Endovascular, Inc.
Cardiovascular · 156d
Cleared Jan 12, 1993
GUIDING CATHETER
K923518 · DQY
Interventional Therapeutics Corp.
Cardiovascular · 182d
Cleared Jan 12, 1993
CLEAN CUFF BLOOD PRESSURE CUFF LINER
K925352 · DXQ
Steridyne Corp.
Cardiovascular · 82d
Cleared Jan 11, 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 223d
Cleared Jan 07, 1993
TRANSDUCER, PRESSURE, CATHETER TIP
K920580 · DXO
Medamicus, Inc.
Cardiovascular · 332d
Cleared Jan 07, 1993
ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD
K920870 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 317d
Cleared Jan 07, 1993
ES1700 ECG MODULATOR
K922783 · DXH
Epic Systems, Inc.
Cardiovascular · 212d