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
11641–11664 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 25, 1993
CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
K924554 · LYK
Clarus Medical Systems, Inc.
Cardiovascular · 169d
Cleared Feb 25, 1993
CATHETER INTRODUCER
K924562 · DYB
Luther Medical Products, Inc.
Cardiovascular · 169d
Cleared Feb 25, 1993
MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR
K925411 · DSI
Accucore, Inc.
Cardiovascular · 122d
Cleared Feb 25, 1993
SERIES 1500 DEFIBRILLATOR, MODIFICATION
K926172 · MKJ
Marquette Electronics, Inc.
Cardiovascular · 86d
Cleared Feb 23, 1993
.25' ULTRA-SELECT GUIDEWIRE
K922060 · DQX
Microvena Corp.
Cardiovascular · 295d
Cleared Feb 22, 1993
COMPRESSAR UNIVERSAL (TM) SYSTEM
K925809 · DXC
Instromedix, Inc.
Cardiovascular · 97d
Cleared Feb 22, 1993
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450 · DQE
Baxter Healthcare Corp
Cardiovascular · 60d
Cleared Feb 19, 1993
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
K926250 · DTN
Electromedics, Inc.
Cardiovascular · 67d
Cleared Feb 18, 1993
ECG ELECTRODE
K923558 · DRX
Lectec Corp.
Cardiovascular · 216d
Cleared Feb 18, 1993
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
K924354 · DTW
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 190d
Cleared Feb 17, 1993
AMBULATORY (HOLTER) RECORDING, MODIFICATION
K922027 · DSI
Biosensor Corp.
Cardiovascular · 328d
Cleared Feb 16, 1993
LEMAITRE RETROGRADE VALVULOTOME
K924171 · MGZ
Vascutech, Inc.
Cardiovascular · 182d
Cleared Feb 12, 1993
ANGIOGRAPHIC CATHETER -- MODIFICATION
K922101 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 282d
Cleared Feb 12, 1993
FLOW CONTROL VALVE, CAT. NO. ACV-38
K922356 · MJJ
American Omni Medical, Inc.
Cardiovascular · 269d
Cleared Feb 12, 1993
QUICKLAMP SYSTEM
K923085 · DXC
Disco, Inc.
Cardiovascular · 232d
Cleared Feb 12, 1993
TRIGUIDE-PLUS GUIDING CATHETER
K923245 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 225d
Cleared Feb 12, 1993
ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
K925381 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 112d
Cleared Feb 12, 1993
SCHNEIDER HYDRO-SIL GUIDEWIRE
K925804 · DQX
Schneider Intl., Ltd.
Cardiovascular · 88d
Cleared Feb 12, 1993
CORDIS STEERABLE GUIDEWIRE
K925833 · DQX
Cordis Corp.
Cardiovascular · 88d
Cleared Feb 10, 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · DSP
Datascope Corp.
Cardiovascular · 310d
Cleared Feb 10, 1993
TORQR SERIES DIAGNOSTIC EP CATHETERS
K923915 · DRF
Cardiorhythm
Cardiovascular · 204d
Cleared Feb 10, 1993
VOYAGR SERIES DIAGNOSTIC EP CATHETERS
K923916 · DRF
Cardiorhythm
Cardiovascular · 197d
Cleared Feb 09, 1993
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
K914273 · DSK
A&D Engineering, Inc.
Cardiovascular · 504d
Cleared Feb 09, 1993
HI-TORQUE SPORT-T(TM) GUIDE WIRE
K915554 · DQX
Peripheral Systems Group
Cardiovascular · 426d