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
5593–5616 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 17, 2010
GORE HYBRID VASCULAR GRAFT
K093934 · DSY
W.L. Gore & Associates
Cardiovascular · 85d
Cleared Mar 17, 2010
WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
K092558 · DXN
Harvard Medical Devices , Ltd.
Cardiovascular · 209d
Cleared Mar 16, 2010
LITEPAC, MODEL 682
K100490 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 25d
Cleared Mar 16, 2010
NEUROSCOUT STEERABLE GUIDEWIRE
K100351 · DQX
Codman & Shurtleff, Inc.
Cardiovascular · 32d
Cleared Mar 15, 2010
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
K093232 · DYB
Great Batch Medical
Cardiovascular · 152d
Cleared Mar 08, 2010
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K093788 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 89d
Cleared Mar 05, 2010
CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
K100446 · JOW
Devon Medical, Inc.
Cardiovascular · 16d
Cleared Mar 05, 2010
ACUITY BREAK-AWAY GUIDE CATHETER
K093969 · DQY
Cardiac Pacemakers, Inc.
Cardiovascular · 72d
Cleared Mar 01, 2010
NMI FC
K091634 · DTL
Navilyst Medical, Inc.
Cardiovascular · 270d
Cleared Feb 26, 2010
TRAILRUNNER GUIDEWIRES
K092965 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 154d
Cleared Feb 26, 2010
TELESENTRY, MODEL TS01
K092947 · DSI
Scottcare Corporation
Cardiovascular · 155d
Cleared Feb 26, 2010
ASAHI ZENYTEEX GUIDING CATHETER
K091188 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 309d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
St Jude Medical
Cardiovascular · 65d
Cleared Feb 25, 2010
ITG VASCULAR ACCESS SYSTEM, MODEL 300
K091006 · DYB
Arstasis, Inc.
Cardiovascular · 323d
Cleared Feb 24, 2010
TRAXCESS DOCKING WIRE
K093647 · DQX
MicroVention, Inc.
Cardiovascular · 91d
Cleared Feb 24, 2010
FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
K093026 · DYB
Footprint Medical
Cardiovascular · 148d
Cleared Feb 24, 2010
12SL ECG ANALYSIS PROGRAM
K092369 · MHX
Ge Medical Systems Information...
Cardiovascular · 203d
Cleared Feb 19, 2010
ELI PC ELECTROCARDIOGRAPH
K093339 · DPS
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared Feb 18, 2010
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
K091029 · MCW
Rex Medical
Cardiovascular · 314d
Cleared Feb 17, 2010
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
K093650 · DTY
Medtronic, Inc.
Cardiovascular · 84d
Cleared Feb 17, 2010
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
K092175 · PDU
Flowcardia, Inc.
Cardiovascular · 211d
Cleared Feb 16, 2010
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT
K093824 · DXN
Health & Life Co., Ltd.
Cardiovascular · 64d
Cleared Feb 16, 2010
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT...
K093515 · DQX
Brivant, Ltd.
Cardiovascular · 95d
Cleared Feb 12, 2010
GLIDER PTA BALLOON CATHETER
K094019 · DQY
Trireme Medical, Inc.
Cardiovascular · 45d