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
9193–9216 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 03, 2000
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT...
K001057 · DSI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Apr 28, 2000
8100 VITAL SIGNS MONITOR
K001020 · MWI
Criticare Systems, Inc.
Cardiovascular · 29d
Cleared Apr 28, 2000
CORDIS INTRODUCER GUIDE
K001136 · DQY
Cordis Corp.
Cardiovascular · 18d
Cleared Apr 28, 2000
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
K993564 · MCW
Possis Medical, Inc.
Cardiovascular · 190d
Cleared Apr 27, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE,...
K001138 · DTM
Medtronic Vascular
Cardiovascular · 17d
Cleared Apr 27, 2000
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
K994171 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 139d
Cleared Apr 25, 2000
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K000255 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 88d
Cleared Apr 25, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT...
K001021 · DTZ
Dideco S.P.A.
Cardiovascular · 26d
Cleared Apr 21, 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
K000956 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 28d
Cleared Apr 19, 2000
LIFECARD CF COMPACT RECORDER
K001025 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 20d
Cleared Apr 17, 2000
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
K993677 · DWF
Medtronic Vascular
Cardiovascular · 168d
Cleared Apr 14, 2000
FIXATION STYLETS, MODELS 335-287 AND 335-288
K000366 · DRB
Accufix Research Institute
Cardiovascular · 70d
Cleared Apr 14, 2000
AGILITY STEERABLE GUIDEWIRE
K001033 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 14d
Cleared Apr 13, 2000
CTC DVT-1 CALF GARMENT, MODEL DVT-1
K000147 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 86d
Cleared Apr 13, 2000
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
K000168 · MHX
Datex-Ohmeda
Cardiovascular · 84d
Cleared Apr 13, 2000
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
K000206 · DRX
Axelgaard Mfg. Co., Ltd.
Cardiovascular · 83d
Cleared Apr 13, 2000
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON...
K000570 · LIT
Boston Scientific Corp
Cardiovascular · 51d
Cleared Apr 13, 2000
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
K000824 · DYB
Medamicus, Inc.
Cardiovascular · 30d
Cleared Apr 13, 2000
TFX MEDICAL STYLET CATHETER
K992664 · DRB
Tfx Medical Group
Cardiovascular · 248d
Cleared Apr 13, 2000
LEMAITRE OCCLUSION CATHETER
K992942 · MJN
Vascutech, Inc.
Cardiovascular · 226d
Cleared Apr 13, 2000
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
K993608 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 171d
Cleared Apr 13, 2000
EX 45-BP, MODEL 330 132
K994240 · DTB
Biotronik, Inc.
Cardiovascular · 119d
Cleared Apr 12, 2000
SOFTLINE SPRING CLIP
K000098 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 90d
Cleared Apr 11, 2000
POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140...
K972610 · QEZ
Possis Medical, Inc.
Cardiovascular · 1002d