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
14617–14640 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 14, 1986
OSM-1 OXYGEN SATURATION MONITOR
K853331 · JOM
Criticare Systems, Inc.
Cardiovascular · 159d
Cleared Jan 13, 1986
MODEL 3000 OPTICATH COMPUTER
K853018 · DXG
Oximetrix, Inc.
Cardiovascular · 180d
Cleared Jan 13, 1986
POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107
K853446 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 150d
Cleared Jan 13, 1986
BOMED-EEA
K853705 · DRX
Bomed Medical Mfr., Ltd.
Cardiovascular · 131d
Cleared Jan 13, 1986
PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA
K853714 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 130d
Cleared Jan 13, 1986
CUSTOM CORONARY MANIFOLD KITS
K853749 · DTL
Procedure Products, Inc.
Cardiovascular · 126d
Cleared Jan 13, 1986
AMENDMENT LIFEPAK 8, NPN 052
K854117 · DRO
Physio-Control Corp.
Cardiovascular · 96d
Cleared Jan 13, 1986
DEFIGARD 2000
K854175 · LDD
Odam
Cardiovascular · 90d
Cleared Jan 13, 1986
MEDSURG SELDINGER NEEDLE
K854294 · DRC
Medsurg Industries, Inc.
Cardiovascular · 80d
Cleared Jan 13, 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582 · DTB
Medtronic Vascular
Cardiovascular · 59d
Cleared Jan 08, 1986
EMERSON TRO/CATH TROCAR CATHETERS
K853132 · DRC
J. H. Emerson Co.
Cardiovascular · 166d
Cleared Jan 08, 1986
NAVIGATOR
K853747 · DTB
Mainsfield Scientific, Inc.
Cardiovascular · 121d
Cleared Jan 08, 1986
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K854113 · KRI
American Bentley
Cardiovascular · 92d
Cleared Jan 08, 1986
BIO MEDICUS BIO CONSOLE 540
K854133 · DWA
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Jan 08, 1986
CMI 3000
K854233 · DRO
Cardio Management, Inc.
Cardiovascular · 79d
Cleared Jan 08, 1986
PREVIEW XT
K854282 · DSI
Cambridge Medical Instruments, Inc.
Cardiovascular · 76d
Cleared Jan 08, 1986
GEM-6, WITH COMPONENTS
K854357 · DRY
Diamond Electro-Tech, Inc.
Cardiovascular · 71d
Cleared Jan 08, 1986
HEMOSTATIC SIDEARM
K854397 · DTL
Target Therapeutics
Cardiovascular · 69d
Cleared Jan 07, 1986
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
K853038 · DRX
Bio-Detek, Inc.
Cardiovascular · 172d
Cleared Jan 07, 1986
CD-100 CARDIAC MONITOR
K854041 · DRT
Cardio Display Corp.
Cardiovascular · 97d
Cleared Jan 07, 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · DXY
Pacesetter Systems
Cardiovascular · 84d
Cleared Dec 30, 1985
EKG 501 A
K840569 · DPS
Bosch Hearing Instruments, Inc.
Cardiovascular · 691d
Cleared Dec 30, 1985
EKG 503A
K840571 · DPS
Bosch Hearing Instruments, Inc.
Cardiovascular · 691d
Cleared Dec 30, 1985
PERI-GUARD PERICARDIAL PATCH
K842066 · DXZ
Genetic Laboratories, Inc.
Cardiovascular · 616d