Vasomedical Inc

FDA Filings

This page includes the latest FDA filings for Vasomedical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Vasomedical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2435300
FEI Number2435300
NameVASOMEDICAL, INC.
Owner & OperatorVASOMEDICAL, INC.
Contact Address137 Commercial St. Unit 200
Plainview NY 11803 US
Official Correspondent
  • Albert F Clancy
  • x-516-5085821-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address137 Commercial St Ste 200
Plainview, NY 11803 US
Establishment TypeManufacture Medical Device

Registration Number3007663004
FEI Number3007663004
NameAlbert F. Clancy
Owner & OperatorVASOMEDICAL, INC.
Contact Address137 Commercial St. Unit 200
Plainview NY 11803 US
Official Correspondent
  • Albert F Clancy
  • x-516-5085821-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address137 Commercial St Ste 200
Plainview, NY 11803 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
VASOMEDICAL, INC.
 Vasomedical™ EZ™ ECG Monitor A13-0001-02-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 2306 12 CH/ABP COMB Recorder w/Bluetooth A10-2306-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 2305 3 CH/ABP COMB Recorder w/Bluetooth A10-2305-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 2304 12 CH/ABP COMB Recorder A10-2304-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 2303 3 CH/ABP COMB Recorder A10-2303-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 2301 3 CH/ABP COMB Recorder - 7 Lead Patient Cable A10-2301-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 2301 3 CH/ABP COMB Recorder - 5 Lead Patient Cable A10-2301-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth A10-1807-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1806 Ambulatory Blood Pressure Recorder A10-1806-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1805 Ambulatory Blood Pressure Recorder A10-1805-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1308 12 CH ULTRA Recorder w/Bluetooth A10-1308-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder A10-1307-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1306 12 CH Recorder - 10 Lead Patient Cable A10-1306-01-04-022019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1305 3 CH Recorder - 7 Lead Patient Cable A10-1305-01-04-032019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1305 3 CH Recorder - 5 Lead Patient Cable A10-1305-01-04-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1304 12 CH Recorder - 10 Lead Patient Cable A10-1304-01-04-022019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient Cable A10-1303-01-04-022019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 7 Lead Patient Cable A10-1303-01-04-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1201 3 CH Mini ECG Recorder A10-1201-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ Model 1200 2 CH Mini ECG Recorder A10-1200-002019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1201 ECG Holter Mini Recorder A10-1201-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1200 ECG Holter Mini Recorder A10-1200-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1303 Ultra Compact 3 Channel ECG Holter Recorder A10-00872019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder A10-1306-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with Bluetooth A10-2306-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 2305 Combined 3 CH ECG Holter & ABP Monitor with Bluetooth A10-2305-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 2304 Combined 12 Channel ECG Holter & ABP Monitor A10-2304-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor A10-2303-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 2302 Combined 12 Channel ECG Holter & ABP Monitor A10-00862019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor A10-00852019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth A10-1807-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W A10-1806-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W A10-00882019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder A10-1308-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder A10-00822019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder A10-1307-012019-11-08
VASOMEDICAL, INC.
 Vasomedical-Biox™ 1305 3 Channel ECG Holter Recorder A10-00832019-11-08
VASOMEDICAL, INC.
 Pediatric BP Cuff (small/child) 17-25cm A10-00482019-07-22
VASOMEDICAL, INC.
 Adult BP Cuff (large) 32-42cm A10-00472019-07-22
VASOMEDICAL, INC.
 Adult BP Cuff (standard) 24-32cm A10-00462019-07-22
VASOMEDICAL, INC.
 Signa Electrode Gel, 2 oz V93-0026-12018-10-22
VASOMEDICAL, INC.
 Signa Electrode Gel, 8 oz V93-00262018-10-22
VASOMEDICAL, INC.
 Nu Prep Gel, 4 oz (3 PK) V93-0025-12018-10-22
VASOMEDICAL, INC.
 Thigh Cuff, Large V10-0022-42018-07-06
VASOMEDICAL, INC.
 Thigh Cuff, Medium V10-0022-32018-07-06
VASOMEDICAL, INC.
 Thigh Cuff, Small V10-0022-22018-07-06
VASOMEDICAL, INC.
 Thigh Cuff, X-Small V10-0022-12018-07-06
VASOMEDICAL, INC.
 Cuff Set, XX-Large V23-00772018-07-06
VASOMEDICAL, INC.
 Cuff Set, X-Large V23-00012018-07-06
VASOMEDICAL, INC.
 Cuff Set, Large V23-00022018-07-06
VASOMEDICAL, INC.
 Cuff Set, Medium V23-00032018-07-06
VASOMEDICAL, INC.
 Cuff Set, Small V23-00042018-07-06
VASOMEDICAL, INC.
 Cuff Set, X-Small V23-00052018-07-06
VASOMEDICAL, INC.
 Electrodes (600 per case) V93-00202018-07-06
VASOMEDICAL, INC.
 ECG Cable Adaptor-for use with V10-0017 (Model TS3) V83-00662018-07-06
VASOMEDICAL, INC.
 3 Lead Integrated ECG Cable with adapter (Model TS3) V10-00212018-07-06
VASOMEDICAL, INC.
 3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) V10-00172018-07-06
VASOMEDICAL, INC.
 3 Lead Integrated ECG Cable (AngioNew® V & VI) A12-00332018-07-06
VASOMEDICAL, INC.
 Roll ECG Paper, 240 ft. (Model MC2) 2-1282018-07-06
VASOMEDICAL, INC.
 Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) V93-00032018-07-06
VASOMEDICAL, INC.
 Vasomedical™ TS-4EECP® Therapy System R10-00002018-07-06
VASOMEDICAL, INC.
 Vasomedical™ TS-4 EECP® Therapy System V10-00002018-07-06
VASOMEDICAL, INC.
 Vasomedical™Lumenair™ EECP® Therapy System R10-0020-12018-07-06
VASOMEDICAL, INC.
 Vasomedical™Lumenair™ EECP® Therapy System V10-0020-12018-07-06
VASOMEDICAL, INC.
 Vasomedical™ AngioNew -VI EECP® Therapy System A12-00042018-07-06
VASOMEDICAL, INC.
 Vasomedical™ AngioNew -VI EECP® Therapy System A12-00032018-07-06
VASOMEDICAL, INC.
 Vasomedical™ AngioNew -V EECP® Therapy System A12-00022018-07-06
VASOMEDICAL, INC.
 Vasomedical™ AngioNew -V EECP® Therapy System A12-00012018-07-06
VASOMEDICAL, INC.
 Electrode, Holter, Button, 1 ea., MP2E-01 A10-1200-042018-07-06
VASOMEDICAL, INC.
 Electrodes, Holter, Button, 40 per Box, MP2E-40 A10-1200-032018-07-06
VASOMEDICAL, INC.
 Electrodes, Holter, Button, 20 per Box, MP2E-20 A10-1200-022018-07-06
VASOMEDICAL, INC.
 Portable case with Belt for 2301/2302 Recorders A10-00432018-07-06
VASOMEDICAL, INC.
 Portable case with Belt for 1805 Monitor A10-00502018-07-06
VASOMEDICAL, INC.
 Portable case with Belt for 1304/1305 Recorder A10-00422018-07-06
VASOMEDICAL, INC.
 Portable Case w/Belt for 1303 Recorder A10-00412018-07-06
VASOMEDICAL, INC.
 Infared Communication Adaptor A10-00222018-07-06
VASOMEDICAL, INC.
 USB SD Card Reader A10-00152018-07-06
VASOMEDICAL, INC.
 12-Ch ECG Holter Patient Cable w/10 Leads A10-00542018-07-06
VASOMEDICAL, INC.
 3-Ch ECG Holter Patient Cable w/7 Leads A10-00532018-07-06
VASOMEDICAL, INC.
 3-Ch ECG Holter Patient Cable w/5 Leads A10-00522018-07-06
VASOMEDICAL, INC.
 2GB SD Memory Card A10-00112018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W Dongle - Mini 1200/1201 2 & 3 CH ECG A10-0122-022018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200/1201 2 & 3 CH ECG, USB A10-0122-012018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200 / 1201, 2 & 3 CH ECG A10-0122-002018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W & Dongle, Comb (3 CH ECG & ABP),USB w/Bluetooth A10-0118-702018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS ABP Analysis & Reporting S/W & Dongle w/Bluetooth A10-0118-602018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & Dongle A10-0118-502018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USB w/Bluetooth A10-0118-402018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W Dongle Only (12 CH ECG & ABP) A10-0118-322018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USB A10-0118-302018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W Dongle Only (3 CH ECG & ABP) A10-0118-222018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS S/W & Dongle, Comb (3 CH ECG & ABP), USB A10-0118-202018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS Analysis & Reporting S/W Dongle Only, 12 CH ECG A10-0118-122018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS Analysis & Reporting S/w & Dongle, 12 CH ECG, USB A10-0118-102018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS Analysis & Reporting Software Dongle Only, 3 CH ECG A10-0118-022018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ ARCS Analysis & Reporting S/W & Dongle, 3 CH ECG, USB A10-0118-002018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ CB Series Analysis & Reporting S/w - 3 & 12 CH ECG & ABP A10-00362018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG & ABP A10-00352018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG A10-00322018-07-06
VASOMEDICAL, INC.
 Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECG A10-00312018-07-06
Albert F. Clancy [VASOMEDICAL, INC.]
Models 1303, 1304, 1306,1307,1308, ARCS2013-01-30
Albert F. Clancy [VASOMEDICAL, INC.]
Models 1804, 1805, 1806, 1807, 2302, 2303, 2304, 2305, 2306, ARCS2013-01-30
Albert F. Clancy [VASOMEDICAL, INC.]
Models 1804, 1805, 1806, 1807, 2302, 2303, 2304, 2305, 2306, ARCS2013-01-30
VASOMEDICAL, INC.
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY2011-06-28
VASOMEDICAL, INC.
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY2011-06-24
Albert F. Clancy [VASOMEDICAL, INC.]
Vasomedical-Biox 2301 ABPECG Record, ARCS2010-07-27
Albert F. Clancy [VASOMEDICAL, INC.]
Vasomedical-Biox 2301 ABPECG Record, ARCS2010-07-27
VASOMEDICAL, INC.
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 23012010-04-02
Albert F. Clancy [VASOMEDICAL, INC.]
Model 1305, ARCS2009-05-04
Albert F. Clancy [VASOMEDICAL, INC.]
Biox2009-05-04
VASOMEDICAL, INC.
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C2009-04-01
VASOMEDICAL, INC.
Lumenair2007-12-05
VASOMEDICAL, INC.
Enhanced External Counterpulsation2007-12-05
VASOMEDICAL, INC.
EECP2007-12-05
VASOMEDICAL, INC.
AngioNew2007-12-05
Albert F. Clancy [VASOMEDICAL, INC.]
Lumenair2007-12-05
Albert F. Clancy [VASOMEDICAL, INC.]
Enhanced External Counterpulsation2007-12-05
Albert F. Clancy [VASOMEDICAL, INC.]
EECP2007-12-05
Albert F. Clancy [VASOMEDICAL, INC.]
AngioNew2007-12-05
VASOMEDICAL, INC.
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY2004-03-01
VASOMEDICAL, INC.
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER2002-06-14
VASOMEDICAL, INC.
EECP THERAPY SYSTEM, MODEL TS32000-12-06

Related Finance Registrations
NCAGE Code3H5E4VASOMEDICAL, INC.
CAGE Code3H5E4VASOMEDICAL, INC.
S.A.M. Registration3H5E4 [197210248]VASOMEDICAL, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020041410179Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyBLADDER FULL SETPANTS CUFF THIGHCUFF FULL SET7 CTN
2019020124788Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyCOTTON PANT12 PKG
2019012823625Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseySPONGE CUSHION 100% COTTON PANT BLADDER39 PKG
2018100227874Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyCUFF PANTS5 PKG
2018040212015Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseySPARE PARTS PANTS .11 PKG
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