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
12937–12960 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 28, 1989
MULTILUMEN CENTRAL VENOUS CATHETER
K885221 · DQO
Bd Becton Dickinson Vacutainer...
Cardiovascular · 373d
Cleared Dec 22, 1989
VOSS VEIN CLAMP
K885161 · DXC
Voss Medical Products
Cardiovascular · 374d
Cleared Dec 22, 1989
SAFE-1
K893704 · DTZ
Polystan C/O Vitalcor, Inc.
Cardiovascular · 218d
Cleared Dec 22, 1989
SAFE-1 VENOUS RESERVOIR
K893705 · DTN
Polystan C/O Vitalcor, Inc.
Cardiovascular · 218d
Cleared Dec 20, 1989
BIOCHEM 3100 OXIMETER
K893877 · DQO
Biochem International, Inc.
Cardiovascular · 208d
Cleared Dec 20, 1989
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492 · DRO
Nihon Kohden America, Inc.
Cardiovascular · 155d
Cleared Dec 20, 1989
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · DTB
Pacesetter Systems
Cardiovascular · 103d
Cleared Dec 20, 1989
INFLATION PRO II
K895836 · MAV
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Dec 20, 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · DTB
Possis Medical, Inc.
Cardiovascular · 41d
Cleared Dec 13, 1989
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.
K894356 · LDD
Phycon
Cardiovascular · 152d
Cleared Dec 13, 1989
MT96000 PAPER CHART RECORDER
K894736 · DSF
Astro-Med, Inc.
Cardiovascular · 139d
Cleared Dec 13, 1989
GEL-TAC(R)
K895009 · LDD
Padeco, Inc.
Cardiovascular · 127d
Cleared Dec 13, 1989
MODEL ELI-100/ST ELECTROCARDIOGRAPH
K895232 · LOS
Mortara Instrument, Inc.
Cardiovascular · 114d
Cleared Dec 13, 1989
VASCULAR CLAMP
K895691 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 83d
Cleared Dec 13, 1989
PE INTERCARDIAC MAPPING SYSTEM (ICMS)
K895916 · DRF
Prucka Engineering, Inc.
Cardiovascular · 64d
Cleared Dec 13, 1989
RED DOT CARDIAC SENSOR SYSTEM
K896155 · DRX
3M Company
Cardiovascular · 50d
Cleared Dec 13, 1989
MINIMON 7133B PATIENT MONITOR
K896386 · DPS
Kontron Instruments, Inc.
Cardiovascular · 37d
Cleared Dec 13, 1989
MEDTRONIC MODEL 5401B TEST CABLE
K896632 · DTC
Medtronic Vascular
Cardiovascular · 21d
Cleared Dec 12, 1989
CLOSED CHEST SUPPORT CIRCUIT
K893207 · DTZ
Medtronic Blood Systems, Inc.
Cardiovascular · 230d
Cleared Dec 12, 1989
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
K894355 · LDD
Phycon
Cardiovascular · 151d
Cleared Dec 12, 1989
ZYMED MODEL 1610
K895208 · DSI
Agilent Technologies
Cardiovascular · 117d
Cleared Dec 12, 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · DTZ
3M Company
Cardiovascular · 84d
Cleared Dec 12, 1989
MARQUETTE 1200 DEFIBRILLATION PADS
K895651 · LDD
Marquette Electronics, Inc.
Cardiovascular · 83d
Cleared Dec 12, 1989
KONTRON KOLORMON 7250 PATIENT MONITOR
K896417 · DPS
Kontron Instruments, Inc.
Cardiovascular · 34d