FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11689–11712 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Jan 06, 1993
ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION
K922787 · DQX
Echocath, Inc.
Cardiovascular · 211d
Cleared Jan 06, 1993
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · KRH
Baxter Healthcare Corp
Cardiovascular · 181d
Cleared Jan 05, 1993
COBE PATIENT MONITORING PRODUCTS
K921343 · DRS
Cobe Cardiovascular, Inc.
Cardiovascular · 292d
Cleared Dec 30, 1992
PRESSSION, SEQUENTIAL
K921608 · JOW
Chattanooga Group, Inc.
Cardiovascular · 271d
Cleared Dec 29, 1992
MARQUETTE SV O2 MODULE
K915073 · DQE
Marquette Electronics, Inc.
Cardiovascular · 417d
Cleared Dec 29, 1992
MARQUETTE SERIES 360 DEFIBRILLATOR
K921487 · LDD
Marquette Electronics, Inc.
Cardiovascular · 274d
Cleared Dec 28, 1992
CENTRA II ANALYSIS SYSTEM
K922171 · DQK
Marquette Electronics, Inc.
Cardiovascular · 234d
Cleared Dec 24, 1992
OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601
K920778 · DXN
Omron Healthcare, Inc.
Cardiovascular · 308d
Cleared Dec 23, 1992
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
K914823 · DXN
Omron Healthcare, Inc.
Cardiovascular · 425d
Cleared Dec 23, 1992
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573 · DTN
Baxter Healthcare Corp
Cardiovascular · 377d
Cleared Dec 23, 1992
MODEL 4280 SURGICAL EXTENSION CABLE
K922899 · DSA
Pace Medical
Cardiovascular · 190d
Cleared Dec 21, 1992
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891 · DQX
Cook, Inc.
Cardiovascular · 301d
Cleared Dec 21, 1992
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 200d
Cleared Dec 21, 1992
DIAGNOSTIC INTRAVASCULAR CATHETER
K923699 · DQO
Applied Vascular
Cardiovascular · 150d
Cleared Dec 18, 1992
BSM-8800A BEDSIDE MONITOR
K920154 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 340d
Cleared Dec 18, 1992
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · DXC
Research Medical, Inc.
Cardiovascular · 294d
Cleared Dec 17, 1992
ES 1500 ECG DEMODULATOR
K921699 · DXH
Epic Systems, Inc.
Cardiovascular · 253d
Cleared Dec 15, 1992
ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)
K924672 · DSI
Agilent Technologies
Cardiovascular · 90d
Cleared Dec 11, 1992
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
K915301 · DTL
Advance Medical Designs, Inc.
Cardiovascular · 386d
Cleared Dec 11, 1992
MERITRANS(TM) DISPOSABLE TRANSDUCER
K920977 · DRS
Merit Medical Systems, Inc.
Cardiovascular · 284d