Diversatek Healthcare Inc

FDA Filings

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

FDA Registration(s)
Registration Number2023374
FEI Number2023374
NameDIVERSATEK HEALTHCARE INC.
Owner & OperatorDIVERSATEK HEALTHCARE
Contact Address9150 COMMERCE CENTER CIR.,#500 --
Highlands Ranch CO 80129 US
Official Correspondent
  • Laura L Boll
  • x-303-4707020-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address9150 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



Registration Number2183446
FEI Number2183446
NameDIVERSATEK HEALTHCARE INC
Owner & OperatorMEDOVATIONS, INC.
Contact Address102 EAST KEEFE AVE. --
Milwaukee WI 53212 US
Official Correspondent
  • LAURA - BOLL
  • x-414-2657620-4806
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address102 EAST KEEFE AVE.
Milwaukee, WI 53212 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare 1201-1062024-02-08
DIVERSATEK HEALTHCARE, INC.
BullDog® 1203-612023-09-04
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-602023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-572023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-542023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-512023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-482023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-452023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-422023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-392023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-362023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-332023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-302023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-272023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-242023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-212023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-182023-08-22
DIVERSATEK HEALTHCARE, INC.
SafeGuide® Single 1215-152023-08-22
DIVERSATEK HEALTHCARE, INC.
PureFlo 1195-702023-07-14
DIVERSATEK HEALTHCARE, INC.
PureFlo 1195-502023-07-14
DIVERSATEK HEALTHCARE, INC.
PureFlo 1195-212023-07-14
DIVERSATEK HEALTHCARE, INC.
PureFlo 1195-022023-07-14
DIVERSATEK HEALTHCARE, INC.
PureFlo 1195-012023-07-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A86-50702023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A86-4300-102023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A86-10702023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare CZAN-BT-622023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare L89-6021-402023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare L89-6020-402023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare GIS-70102023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A86-41202023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A86-41002023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A86-4110-102023-07-10
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare 1201-1012023-06-27
DIVERSATEK HEALTHCARE, INC.
Zvu ZVU-20162023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZPN-BS-502023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZPN-BS-46E2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZPN-BS-462023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZPN-BG-07E2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZPN-BG-072023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZPI-BS-462023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZPI-BG-522023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZIN-BS-512023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZIN-BS-45E2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAN-BT-602023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAN-BS-01E2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAN-BS-012023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAN-BG-44E2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAN-BG-442023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAN-BD-312023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BS-01E2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BS-012023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BL-562023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BL-552023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BL-542023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BG-44E2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BG-442023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare ZAI-BD-312023-06-14
DIVERSATEK HEALTHCARE, INC.
ZepHr Z07-2000-B-B2023-06-14
DIVERSATEK HEALTHCARE, INC.
ZepHr Z07-2000-B-A2023-06-14
DIVERSATEK HEALTHCARE, INC.
Bioview S98-1925-7P12023-06-14
DIVERSATEK HEALTHCARE, INC.
Bioview S98-1925-6P12023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare S98-1925-5P12023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHNS-P2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHNS2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHN52023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHN212023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHN152023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHN10-P2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHN102023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHIS2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHI52023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHI152023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare PHI102023-06-14
DIVERSATEK HEALTHCARE, INC.
inSIGHT H12R-45002023-06-14
DIVERSATEK HEALTHCARE, INC.
inSIGHT Ultima H12R-43002023-06-14
DIVERSATEK HEALTHCARE, INC.
inSIGHT Ultima H12R-20002023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare EFTV-12V2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare D82-31832023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare D82-31822023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare D82-31812023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare D82-31522023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare D82-31512023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare D82-31032023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare CART5R2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A04-2000-S2023-06-14
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare A04R-25002023-06-14
DIVERSATEK HEALTHCARE, INC.
BullDog® 1203-052023-06-13
DIVERSATEK HEALTHCARE, INC.
Medovations® InnerVision® 1465-502023-06-12
DIVERSATEK HEALTHCARE, INC.
MiVu MI-CAB-022023-06-05
DIVERSATEK HEALTHCARE, INC.
MiVu MI-ESO-CAP-3L2023-06-05
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare Z07-PACK2023-05-08
DIVERSATEK HEALTHCARE, INC.
MiVu PRIZM-KIT2023-05-05
DIVERSATEK HEALTHCARE, INC.
MiVu MIVU-KIT2023-05-05
DIVERSATEK HEALTHCARE, INC.
MiVu MI-SYR-012023-05-05
DIVERSATEK HEALTHCARE, INC.
MiVu MI-REG-012023-05-05
DIVERSATEK HEALTHCARE, INC.
MiVu MI-CAB-012023-05-05
DIVERSATEK HEALTHCARE, INC.
Diversatek Healthcare 1201-1002023-02-20
DIVERSATEK HEALTHCARE, INC.
PriZm PRIZMCART-II2022-10-31
DIVERSATEK HEALTHCARE, INC.
PriZm H20-45002022-10-31
Diversatek Healthcare Inc.
Mucosal Integrity Conductivity (MI) Test System2019-12-23
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
MiVu Mucosal Integrity Testing System2019-12-23
DIVERSATEK HEALTHCARE INC [MEDOVATIONS, INC.]
BullDog2019-08-01
DIVERSATEK HEALTHCARE INC [MEDOVATIONS, INC.]
BullDog2019-08-01
DIVERSATEK HEALTHCARE INC [MEDOVATIONS, INC.]
BullDog2019-07-01
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Cadwell2017-01-19
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
MUI Pump2012-06-05
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Pediatric pH probe2012-06-05
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
ACEM2012-06-04
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
ACEM2012-06-04
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
ACEM2012-06-04
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Clinical Innovations probes2012-06-04
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
ComforTEC Plus2011-03-14
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Buffer2011-03-14
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Bioview2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Bioview2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
ZepHr2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
ZVU2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Viscous Swallow Challenge2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Sensor PAC2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Insight G32007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Insight G22007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
InSight Ultima2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
HRIM2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Greenfield2007-12-11
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
ComforTEC Plus Probe1992-11-30
DIVERSATEK HEALTHCARE INC. [DIVERSATEK HEALTHCARE]
Buffer1992-11-30

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