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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
8545–8568 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 23, 2002
PORTABLE INTENSIVE CARE UNIT
K012766 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 159d
Cleared Jan 22, 2002
VANGUARD REPROCESSED INFLATION DEVICES
K012480 · MAV
Vanguard Medical Concepts, Inc.
Cardiovascular · 173d
Cleared Jan 22, 2002
PUMP TUBING
K013578 · DWE
Terumo Cardiovascular Systems Corp.
Cardiovascular · 85d
Cleared Jan 22, 2002
6F MACH1/34356-XXX
K020028 · DQY
Boston Scientific
Cardiovascular · 18d
Cleared Jan 18, 2002
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
K013533 · DRG
General Devices
Cardiovascular · 87d
Cleared Jan 18, 2002
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
K014159 · DSI
Philips Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 18, 2002
PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
K014209 · MKJ
Padpro, LLC
Cardiovascular · 28d
Cleared Jan 17, 2002
ECG HOME
K012012 · DXH
H&C Medical Devices Spa
Cardiovascular · 203d
Cleared Jan 17, 2002
INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
K012759 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 153d
Cleared Jan 17, 2002
MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH...
K013485 · DXN
Microlife Corp.
Cardiovascular · 90d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
K013539 · DXN
Rossmax International , Ltd.
Cardiovascular · 85d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE...
K013583 · DXN
Rossmax International , Ltd.
Cardiovascular · 79d
Cleared Jan 17, 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157 · MKJ
Philips Medical Systems
Cardiovascular · 29d
Cleared Jan 17, 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · DQY
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Jan 17, 2002
SIEMENS INFINITY GATEWAY SUITE
K014213 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Jan 16, 2002
LUMEND PERCUTANEOUS CATHETER
K011562 · DQY
Lumend, Inc.
Cardiovascular · 240d
Cleared Jan 16, 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC...
K013833 · DQX
Guidant Corp.
Cardiovascular · 58d
Cleared Jan 16, 2002
HL168E
K014122 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 16, 2002
NUMED COEFFICIENT PTV CATHETERS
K014124 · OMZ
NuMED, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161 · KRH
St. Jude Medical, Inc.
Cardiovascular · 27d
Cleared Jan 15, 2002
M2376A DEVICELINK SYSTEM, MODEL M2376A
K014181 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 26d
Cleared Jan 14, 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425 · MKJ
Philips Medical Systems
Cardiovascular · 90d
Cleared Jan 11, 2002
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M...
K013598 · DSA
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared Jan 11, 2002
MODIFICATION TO OUTBACK CATHETER
K014117 · DQY
Lumend, Inc.
Cardiovascular · 28d