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
5641–5664 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 14, 2010
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER...
K093659 · DTK
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Jan 14, 2010
RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL...
K093658 · JOW
Renu Medical, Inc.
Cardiovascular · 50d
Cleared Jan 14, 2010
ALBOGRAFT VASCULAR PROSTHESIS
K093231 · MAL
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Jan 14, 2010
TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD...
K092893 · DXN
Tytan Medical Corp.
Cardiovascular · 115d
Cleared Jan 14, 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K092158 · NLH
Sterilmed, Inc.
Cardiovascular · 182d
Cleared Jan 13, 2010
EVALVE STEERABLE GUIDE CATHETER
K093866 · DRA
Evalve, Inc.
Cardiovascular · 27d
Cleared Jan 13, 2010
LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
K093832 · DWA
Levitronix, LLC
Cardiovascular · 30d
Cleared Jan 13, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921,...
K092811 · DXN
Andon Health Co, Ltd.
Cardiovascular · 121d
Cleared Jan 13, 2010
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
K092118 · DQO
Oscor, Inc.
Cardiovascular · 183d
Cleared Jan 12, 2010
LIFENET SYSTEM
K093925 · MSX
Physio-Control, Inc.
Cardiovascular · 21d
Cleared Jan 08, 2010
BLOOD PRESSURE MONITOR, MODEL MD200A
K093013 · DXN
Beijing Choice Electronic Technololgy...
Cardiovascular · 101d
Cleared Jan 08, 2010
MICRO-STICK SET
K091954 · DYB
Medcomp
Cardiovascular · 191d
Cleared Jan 07, 2010
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · DSY
Vascutek, Ltd.
Cardiovascular · 27d
Cleared Jan 07, 2010
CARDIO-WRAP
K090637 · DXZ
Mast Biosurgery USA, Inc.
Cardiovascular · 303d
Cleared Jan 05, 2010
MIKRO-CATH, MODEL 825-0101
K093111 · DXO
Millar Instruments, Inc.
Cardiovascular · 96d
Cleared Jan 05, 2010
THERMODILUTION CATHETER
K083384 · DQO
Biosensors Intl. Pte. , Ltd.
Cardiovascular · 414d
Cleared Dec 30, 2009
BANTAM,48XXXXXX, 50XXXXXX
K093139 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 86d
Cleared Dec 30, 2009
ENABLER-P CATHETER SYSTEM, MODEL 3000
K092174 · DQY
Endocross, Ltd.
Cardiovascular · 162d
Cleared Dec 29, 2009
MARS HOLTER ANALYSIS WORKSTATION
K093141 · DQK
Ge Medical Systems Information...
Cardiovascular · 85d
Cleared Dec 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911,...
K092588 · DXN
Andon Health Co, Ltd.
Cardiovascular · 127d
Cleared Dec 24, 2009
PARADIS VASO SHIELD
K093551 · OMR
Spinemedica, LLC
Cardiovascular · 37d
Cleared Dec 23, 2009
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL...
K093720 · LIT
Boston Scientific Corp
Cardiovascular · 21d
Cleared Dec 23, 2009
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL...
K093636 · LIT
Boston Scientific Corp
Cardiovascular · 29d
Cleared Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
K093452 · DXN
Andon Health Co, Ltd.
Cardiovascular · 48d