Diversatek Healthcare

FDA Filings

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

FDA Registration(s)

• Registration Number: 2023374
• FEI Number: 2023374
• Name: DIVERSATEK HEALTHCARE INC.
• Owner & Operator: DIVERSATEK HEALTHCARE
• Contact Address: 9150 COMMERCE CENTER CIR.,#500 --; Highlands Ranch CO 80129 US
• Official Correspondent:
  • Laura L Boll
  • x-303-4707020-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 9150 Commerce Center Cir Ste 500 ; Highlands Ranch, CO 80129 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN DEN180067 | QIS DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	MiVu Mucosal Integrity Testing System	2019-12-23
PMN K190208 Diversatek Healthcare	Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe	2019-10-03
PMN K971214 | OLV DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K971214 | OLT DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K971214 | JXE DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K971214 | IKN DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K971214 | GWQ DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K971214 | GWJ DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K971214 | GWF DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K971214 | GWE DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Cadwell	2017-01-19
PMN K823701 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	MUI Pump	2012-06-05
PMN K013951 | FFT DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Pediatric pH probe	2012-06-05
PMN K111013 | MYE DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	ACEM	2012-06-04
PMN K111013 | JOM DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	ACEM	2012-06-04
PMN K111013 | FFZ DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	ACEM	2012-06-04
PMN K022023 | KLA DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Clinical Innovations probes	2012-06-04
PMN K931963 | FFT DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	ComforTEC Plus	2011-03-14
PMN K931963 | FFT DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Buffer	2011-03-14
PMN K961056 | KLA DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Bioview	2007-12-11
PMN K961056 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Bioview	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	ZepHr	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	ZVU	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Viscous Swallow Challenge	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Sensor PAC	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Insight G3	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Insight G2	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	InSight Ultima	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	HRIM	2007-12-11
PMN K012232 | FFX DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Greenfield	2007-12-11
FFT DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	ComforTEC Plus Probe	1992-11-30
FFT DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]	Buffer	1992-11-30

Similar & Related FDA Registered Companies

• Diversatek Healthcare Co
• Diversatek Healthcare Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092993	Vung Tau,Vietnam -> Los Angeles, California	BITE BLOCK AND CLEANING BRUSH/MEDICAL DEVICE	15 PKG
2020092619693	Shanghai ,China (Mainland) -> Los Angeles, California	PLASTIC SHAFT	40 PKG
20200926619	Vung Tau,Vietnam -> Los Angeles, California	BITE BLOCK AND CLEANING BRUSH/MEDICAL DEVICE	15 PKG
20200924473	Vung Tau,Vietnam -> Los Angeles, California	BITE BLOCK AND CLEANING BRUSH/MEDICAL DEVICE	15 PKG
2020092315553	Shanghai ,China (Mainland) -> Los Angeles, California	PLASTIC SHAFT	40 PKG
20200923228	Vung Tau,Vietnam -> Los Angeles, California	BITE BLOCK AND CLEANING BRUSH/MEDICAL DEVICE	15 PKG
2020092220260	Shanghai ,China (Mainland) -> Los Angeles, California	PLASTIC SHAFT	40 PKG
20200919801	Vung Tau,Vietnam -> Los Angeles, California	BITE BLOCK AND CLEANING BRUSH/MEDICAL DEVICE	15 PKG