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
7657–7680 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · DQX
Boston Scientific Corp
Cardiovascular · 28d
Cleared Apr 29, 2004
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
K032568 · DXQ
Med Textile, LLC
Cardiovascular · 253d
Cleared Apr 29, 2004
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
K040228 · DPW
Medi-Stim A/S
Cardiovascular · 87d
Cleared Apr 29, 2004
SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL...
K040690 · OCL
Cryocath Technologies, Inc.
Cardiovascular · 44d
Cleared Apr 29, 2004
ATLANTIS SR, MODEL C4020
K040776 · DQO
Boston Scientific Corp
Cardiovascular · 34d
Cleared Apr 27, 2004
PORTACLAMP
K033085 · DXC
Cardio Life Research, S.A.
Cardiovascular · 211d
Cleared Apr 27, 2004
CLIRPATH EXCIMER LASER CATHETER
K040067 · PDU
Spectranetics Corp.
Cardiovascular · 104d
Cleared Apr 27, 2004
HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)
K040440 · DWJ
Http Hypothermia Therapy
Cardiovascular · 67d
Cleared Apr 27, 2004
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
K040632 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 48d
Cleared Apr 26, 2004
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME...
K040287 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 80d
Cleared Apr 23, 2004
MODIFICATION TO OUTBACK CATHETER
K040771 · DQY
Lumend, Inc.
Cardiovascular · 29d
Cleared Apr 23, 2004
LIFEPAK 12
K040775 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 28d
Cleared Apr 20, 2004
SONO TT ULTRASONIC FLOWCOMPUTER
K040909 · DPW
Em-Tec GmbH
Cardiovascular · 12d
Cleared Apr 19, 2004
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
K040786 · DQX
Neometrics, Inc.
Cardiovascular · 21d
Cleared Apr 15, 2004
EP DEFLECTABLE CATHETERS
K033963 · DRF
Ep Medsystems, Inc.
Cardiovascular · 115d
Cleared Apr 15, 2004
AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T
K040528 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 45d
Cleared Apr 14, 2004
CARDIOVIT AT-102
K031557 · DPS
Schiller AG
Cardiovascular · 331d
Cleared Apr 14, 2004
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND...
K040415 · DXZ
Synovis Surgical Innovations
Cardiovascular · 56d
Cleared Apr 13, 2004
TELECARE D.R. SERVER SOFTWARE SYSTEM
K033133 · MWI
Healthcare Vision, Inc.
Cardiovascular · 196d
Cleared Apr 13, 2004
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
K040342 · KRD
Boston Scientific Corp
Cardiovascular · 61d
Cleared Apr 09, 2004
AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY
K033397 · DXN
Avita Corporation
Cardiovascular · 168d
Cleared Apr 09, 2004
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
K040056 · MKJ
Bio-Detek, Inc.
Cardiovascular · 87d
Cleared Apr 09, 2004
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
K040256 · MKJ
Bio-Detek, Inc.
Cardiovascular · 65d
Cleared Apr 07, 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · DTB
Oscor, Inc.
Cardiovascular · 34d