FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10945–10968 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 21, 1994
DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION
K935985 · DQO
Deroyal Industries, Inc.
Cardiovascular · 372d
Cleared Dec 20, 1994
WINNER SELF-TAKING HOME BLOOD PRESSURE KIT
K942163 · DXN
Winmed Instruments Mfg. Corp.
Cardiovascular · 230d
Cleared Dec 20, 1994
FOCUS BALLOON DILATATION CATHETER
K944016 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 126d
Cleared Dec 20, 1994
CVD SMALL VESSEL BALLOON DILATATION CATHETER
K945465 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 43d
Cleared Dec 19, 1994
THE PROMPT GUIDWIRE
K943522 · DQX
Cordis Corp.
Cardiovascular · 154d
Cleared Dec 15, 1994
ATRIUM'S HYBRID PTFE
K933391 · DYF
Atrium Medical Corp.
Cardiovascular · 521d
Cleared Dec 15, 1994
HYPERGRAPH
K941162 · DSB
Dermed Diagnostics, Inc.
Cardiovascular · 279d
Cleared Dec 15, 1994
CARDIAC OUTPUT OPTION 39
K943256 · DXG
Medical Data Electronics
Cardiovascular · 162d
Cleared Dec 13, 1994
ANGIOGRAPHY SYRINGE KITS
K933846 · DXT
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 494d
Cleared Dec 13, 1994
HIGH PRESSURE TUBING
K941978 · DQO
Abbott Laboratories
Cardiovascular · 243d
Cleared Dec 09, 1994
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
K944460 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared Dec 08, 1994
GUIDE WIRE
K942453 · DQX
Boston Scientific Corp
Cardiovascular · 199d
Cleared Dec 08, 1994
CYPRESS MEDICAL PRODUCTS STETHOSCOPE
K945082 · LDE
Cypress Medical Products, Ltd.
Cardiovascular · 52d
Cleared Dec 07, 1994
FAST-PATCH
K941970 · MKJ
Physio-Control Corp.
Cardiovascular · 229d
Cleared Dec 05, 1994
MODEL ACUITY CENTRAL STATION
K935846 · DSI
Protocol Systems, Inc.
Cardiovascular · 362d
Cleared Dec 05, 1994
ALTAIR-DISC RECORDER
K942565 · DQK
Burdick Corp.
Cardiovascular · 188d
Cleared Dec 05, 1994
CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER
K942704 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 180d
Cleared Dec 02, 1994
R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD
K935371 · DRX
R2 Medical Systems
Cardiovascular · 389d
Cleared Nov 30, 1994
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
K940079 · DYB
Arrow Intl., Inc.
Cardiovascular · 327d
Cleared Nov 30, 1994
ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE...
K940302 · DSA
Arbo Medical, Inc.
Cardiovascular · 310d
Cleared Nov 30, 1994
SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER
K943622 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 126d
Cleared Nov 30, 1994
ACOUSTIC RECORDER
K943726 · DQC
Technology Applications Assoc., Inc.
Cardiovascular · 120d
Cleared Nov 30, 1994
VARIOUS STETHOSCOPES
K944337 · LDE
Rud Riester GmbH & CO KG
Cardiovascular · 85d
Cleared Nov 29, 1994
BLOOD PRESSURE METER MODEL NO. BPM888
K941490 · DXN
Integrated Display Technology, Ltd.
Cardiovascular · 246d