FDA.reportPublic FDA data

DIVERSATEK HEALTHCARE INC.

Matched from indexed company URL: Diversatek Healthcare

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20233742023374DIVERSATEK HEALTHCARE INC.1Y2026-01-019150 Commerce Center Cir Ste 500 Highlands Ranch CO US 80129
21834462183446DIVERSATEK HEALTHCARE INC1Y2026-01-01102 EAST KEEFE AVE. Milwaukee WI US 53212

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00816734021217InnerVision® - Wolf/Dyonics Light Source Adaptor800-558-6408sales@diversatekhc.com
00816734021224InnerVision® - Fiber Optic Cable with Circon-ACMI/Olympus Connector, 40 French800-558-6408sales@diversatekhc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
61001909488380K972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)FAT1998-02-02
343222061655848K971214KILOWINGWE1998-06-11
61001366635629K964561ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TAFDG1997-02-11
343221203557380K961056BIOVIEW MODEL S960000KLA1996-06-06
61001985861365K942944IRRIGATION/BIPOLAR SETGEI1994-09-27
343221552946265K931963SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBEFFT1994-09-28
61001417659819K924646OVER THE GUIDEWIRE DILATATION SYSTEMKNQ1994-12-05
61001845262824K922038CO2 INSUFFLATION TUBINGHIF1992-10-13
61001495634431K900003SYSTEM TEN MODEL 100 SURGICAL SYSTEMJDX1990-03-16
61002039359004K833054GASTRIC SUMP TUBESKNT1983-10-19
343221206094879K823701MOTILITY CATHETERSFFX1983-02-15
61001366296786K790209FILTER SYSTEM, ALTNER DISPOSABLEGAZ1979-02-26
61001946924729K232118ANDORATE® Valve KitODC2023-10-16
61002073262079K230932ANDORATE® Valve KitOCX2023-07-07
61001280719813K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveKTI2023-05-11
343221891940739K230056MiVu™ Esophageal Endo CapQIS2023-04-25
61002033717623K222734Diversatek Healthcare PureFlo Irrigation System / Water Bottle TubingOCX2022-11-08
61001599960312K222006Sclerotherapy & Endoscopic NeedlesFBK2023-04-03
61001593330517K211787HemoclipPKL2022-03-03
61001547855169K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveODC2020-06-24
61001237484314K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorODC2020-06-18
61001891375395K200479AquaPulse Auxiliary Water ConnectorOCX2020-05-15
61001225729500K191231Andorate Auxiliary Water Connector, Andorate Valves SetODC2019-06-07
343221315595554K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX2019-10-03
61001760626905K182998Andorate Auxiliary Water ConnectorOCX2019-04-17
61001008126366K181509Endorate Valve SetsOCX2018-07-06
61002044087830K172729Polypectomy SnareFDI2018-05-21
61001597086876K172727HemoclipPKL2018-04-16
61001431777082K150024Bissinger Monopolar CablesGEI2015-02-20
61002028043665K142068BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILEOCX2015-03-10
343221913200037K111013ACEMFFZ2011-12-19
61001394780375K093079TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-UKNS2010-08-02
343221956253021K062222UNITIP HIGH RESOLUTION CATHETERFFX2007-03-15
343221000303481K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500KLA2003-01-07
343221409249042K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBEFFT2002-02-28
343221622113643K012232INSIGHT, MODEL S980000FFX2002-06-07
343221034231749DEN180067Mucosal Integrity Conductivity (MI) Test SystemQIS2019-12-23
61001629967941
61001665865268
61001714797305
61001740479280
61001872136532
343221907208818
61001006180822
61001142883990
61001208058118
61001290866053
61001512583055
61001563831658
61001654661259
61001724489378
61001751911571
61001869164733
61002028438239
61002063640344

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCX62023-07-07
ODC42023-10-16
FFX42019-10-03
QIS32023-04-25
FFT32002-02-28
PKL22022-03-03
GEI22015-02-20
KLA22003-01-07
HIF21992-10-13
KTI12023-05-11
FBK12023-04-03
FDI12018-05-21
FFZ12011-12-19
KNS12010-08-02
GWE11998-06-11
FAT11998-02-02
FDG11997-02-11
KNQ11994-12-05
JDX11990-03-16
KNT11983-10-19
GAZ11979-02-26

PMN#

GUDID#

80 records. Showing 1-40. Next