Osko Inc

FDA Filings

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

FDA Registration(s)
Registration Number3010666400
FEI Number3010666400
NameOSKO,INC
Owner & OperatorOSKO, INC.
Contact Address8085 NW 90TH STREET
Miami FL 33166 US
Official Correspondent
  • Hanmaru Chon
  • 001-305-5997161-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address8085 NW 90th St
Miami, FL 33166 US
Establishment Type
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
OSKO,INC [OSKO, INC.]
x-ray system EzRay Air Portable (Model: VEX-P300)2020-03-19
OSKO,INC [OSKO, INC.]
XmaruView V12020-03-19
OSKO,INC [OSKO, INC.]
x-ray system, EzRay Air Portable (Model VEX-P300)2020-03-19
OSKO,INC [OSKO, INC.]
Xmaru View V12020-03-19
OSKO,INC [OSKO, INC.]
JPI Grid 103 Line2019-11-18
OSKO,INC [OSKO, INC.]
LUC-9M2019-10-25
OSKO,INC [OSKO, INC.]
LUC-15U2019-10-25
OSKO,INC [OSKO, INC.]
LUC-14U2019-10-25
OSKO,INC [OSKO, INC.]
LUC-11M2019-10-25
OSKO,INC [OSKO, INC.]
LUC-10M2019-10-25
OSKO,INC [OSKO, INC.]
E7252X/FX2019-10-25
OSKO,INC [OSKO, INC.]
E7242X/FX2019-10-25
OSKO,INC [OSKO, INC.]
E7239X/FX2019-10-25
OSKO, INC.
 DCX 2019-06-18
OSKO, INC.
 Smart Stitching 2019-05-23
OSKO, INC.
 Edge Air 2019-05-07
OSKO, INC.
 Edge 2019-05-07
OSKO, INC.
 XR5 2018-07-06
OSKO, INC.
 ELIAN 2018-07-06
OSKO, INC.
 RU3000 2018-07-06
OSKO,INC [OSKO, INC.]
Wall bucky stand; BS-202018-05-04
OSKO,INC [OSKO, INC.]
Bucky Stand; U-arm Stand; Universal stand; Wall bucky stand; Wall stand; LSS-1000, SU-30012018-05-04
OSKO,INC [OSKO, INC.]
Bucky Stand; NK17FY, NK17SB2018-05-04
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imager (Flat Panel/Digital Imager); Edge2017-11-03
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imager (Flat Panel/Digital Imager); 1717SCC2017-11-03
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imager (Flat Panel/Digital Imager); Edge Air2017-11-03
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imager (Flat Panel/Digital Imager); 1717WCC2017-11-03
OSKO,INC [OSKO, INC.]
System, Image Processing, Radiological2017-11-03
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imager (Flat Panel/Digital Imager)2017-10-31
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imager (Flat Panel/Digital Imager)2017-10-09
Osko, Inc.
Edge Digital Flat Panel X-ray Detector2017-10-06
OSKO, INC.
Edge Air Digital Flat Panel X-ray Detector2017-10-06
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imager (Flat Panel/Digital Imager) - 1717SCC2017-09-28
OSKO, INC.
Smart Stitching Software System, Image Processing, Radiological2017-07-28
OSKO,INC [OSKO, INC.]
1717WCC / 1717WGC2017-02-21
OSKO,INC [OSKO, INC.]
Digital Flat Panel X-Ray Detector 1417WCC2017-02-21
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imaging Device, Digital Flat Panel X-ray Detector, 1417WGC2017-02-21
OSKO,INC [OSKO, INC.]
Digital Flat Panel X-Ray Detector 1717SGC2017-02-21
OSKO,INC [OSKO, INC.]
6-way floating table; ST-3300; ST-2300; ST10002017-02-20
OSKO,INC [OSKO, INC.]
Generator - 65KW / 3-phase / 480 VAC2017-02-20
OSKO,INC [OSKO, INC.]
Generator - 65KW / 3-phase / 400 VAC2017-02-20
OSKO,INC [OSKO, INC.]
Generator - 50KW / 3-phase / 400-480 VAC2017-02-20
OSKO,INC [OSKO, INC.]
Generator - 50KW / 3-phase / 208-230 VAC2017-02-20
OSKO,INC [OSKO, INC.]
Generator - 40KW / 1-phase / 208-230 VAC2017-02-20
OSKO,INC [OSKO, INC.]
Generator (PXR-401B) - 40KW / 1-phase / 220/240 VAC2017-02-20
OSKO,INC [OSKO, INC.]
Generator (POX-100BT) - 5KW / 1-phase / 110 VAC2017-02-20
OSKO,INC [OSKO, INC.]
XR52015-06-03
OSKO,INC [OSKO, INC.]
XR5 Diagnostic X-ray System2015-06-03
OSKO,INC [OSKO, INC.]
Solid State X-Ray Imaging Device, Digital Flat Panel X-ray Detector, 1417WGC2015-06-03
OSKO,INC [OSKO, INC.]
Generator - 50KW / 3-phase / 400-480 VAC2015-06-03
OSKO,INC [OSKO, INC.]
Generator - 50KW / 3-phase / 208-230 VAC2015-06-03
OSKO,INC [OSKO, INC.]
Digital Flat Panel X-Ray Detector 1717SGC2015-06-03
OSKO,INC [OSKO, INC.]
Digital Flat Panel X-Ray Detector 1417WCC2015-06-03
OSKO,INC [OSKO, INC.]
DCX2015-06-03
OSKO,INC [OSKO, INC.]
6-way floating table2015-06-03
OSKO,INC [OSKO, INC.]
1717WCC / 1717WGC2015-06-03
OSKO, INC.
Diagnostic X-ray System2015-05-07
OSKO,INC [OSKO, INC.]
RU30002015-04-17
OSKO,INC [OSKO, INC.]
ELIAN2015-04-17
OSKO, INC.
ELIAN Digital Diagnostic X-ray System2015-04-08
OSKO,INC [OSKO, INC.]
Tube Stand; SFC-31F2014-01-22
OSKO,INC [OSKO, INC.]
Tube Stand; LSS-20002014-01-22
OSKO,INC [OSKO, INC.]
OTC(Overhead Tube Crane). SC-30002014-01-22
OSKO,INC [OSKO, INC.]
OTC(Overhead Tube Crane). SC-20002014-01-22
OSKO,INC [OSKO, INC.]
ELIAN-Tube mount, X-ray, Diagnostic2014-01-22

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020071351257Pusan,South Korea -> Long Beach, CaliforniaPARTS AND ACCESSORIES FOR MACHINES10 PKG
2020051341080Pusan,South Korea -> Long Beach, CaliforniaPARTS FOR X-RAY TOTAL 79 CTNS OF 50 CTNS OF PARTS OF APPARATUS BASED ON THE USE OF X-RAY 29 CTNS OF FLAT PANEL DETECTOR79 CTN
2020042260801Pusan,South Korea -> Long Beach, CaliforniaPARTS OF APPARATUS BASED ON THE USE OF 87 CTNS OF 70 CTNS OF PARTS OF APPARATUS BASED ON THE USE OF X-RAY INVOICE NO. RY200331-SJ007 P/O NO 1409, 142687 CTN
2020030527991Pusan,South Korea -> Long Beach, CaliforniaX-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 29 PKGS OF X RAY SYSTEM EQUIPMENT SUBSTITUTED AT CARRIER S CONVENIENCE.29 PKG
2020021947012Pusan,South Korea -> Long Beach, CaliforniaX-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 30 PKGS OF X-RAY SYSTEM(XR5 6WAY)30 PKG
2020013053454Pusan,South Korea -> Los Angeles, CaliforniaX-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 6 CTNS OF APPARATUS FOR X-RAY SU-3000 U-ARM STAND SN SU32001011-SU32001015 ST-1000 BASIC TABLE6 CTN
2019122837463Pusan,South Korea -> Los Angeles, CaliforniaX-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 16 PACKAGES OF X-RAY SYSTEM(XR5 4WAY) LSS-1000(WITHOUT BUCKY) LSS-2000(WITH RAIL) TABLE TOP16 PKG
2019122357738Pusan,South Korea -> Los Angeles, CaliforniaPARTS FOR X- RAY SYSTEM16 PKG
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.