FDA.reportPublic FDA data

CIVCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088078663008807866CivaTech Oncology Inc.1N2026-01-01627 Davis Dr. Tech 7, Suite 200 Morrisville NC US 27560
30342864261937223CIVCO Medical Instruments Co., Inc.1N2026-01-01750 Lois Lane Coralville IA US 52241
19372231937223CIVCO Medical Instruments Co., Inc.1N2020-04-25102 FIRST ST. SOUTH Kalona IA US 52247
30121671283012167128CIVAL MEDTECH GMBH1N2020-04-25Stockacher Str. 134 Tuttlingen Baden-Wurttemberg DE 78532

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
00841436108324TEE Kit - Rail Adapter, TEE Transducer Holder, CIV-Flex™ Transducer Covers (12)+1(319)248-6502regulatory@civco.com
00841436108331TEE Kit - Table Adapter, TEE Transducer Holder, CIV-Flex™ Transducer Covers (12)+1(319)248-6502regulatory@civco.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3350731261918852K992152GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFFITX1999-08-17
338081261918852K992152GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFFITX1999-08-17
3350731870868781K972672BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORYITX1997-07-29
338081870868781K972672BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORYITX1997-07-29
3350731096800380K970515GENERAL PURPOSE LATEX TRANSDUCER COVERSITX1997-06-20
338081096800380K970515GENERAL PURPOSE LATEX TRANSDUCER COVERSITX1997-06-20
3350731538451169K970514DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDEITX1997-06-20
338081538451169K970514DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDEITX1997-06-20
338081079681856K970513GENERAL PURPOSE TRANDUCER COVERITX1997-06-20
3350731079681856K970513GENERAL PURPOSE TRANDUCER COVERITX1997-06-20
338081626109211K943393CIVCO PROBE BOOT/CORD COVERKKX1995-02-02
338081099402808K895614CIVCO LATEX ULTRASOUND SHEATHSIYO1989-12-14
3350731862926184K875240TRANS/V NEEDLE GUIDEIYO1988-04-15
338081862926184K875240TRANS/V NEEDLE GUIDEIYO1988-04-15
338081711709596K875236TRANS/P NEEDLE GUIDEIYO1988-04-15
3350731711709596K875236TRANS/P NEEDLE GUIDEIYO1988-04-15
338081207911665K875128TRANS/R NEEDLE GUIDEIYO1988-04-15
3350731207911665K875128TRANS/R NEEDLE GUIDEIYO1988-04-15
3350731855693362K233109TP Pivot Pro™ Needle GuideITX2023-12-22
3350731315777367K231783VitroPROITX2023-11-14
3350731665606171K211270CIV-Clear coverITX2021-09-13
1547731622374735K191324CivaDermKXK2019-09-20
3350731647373521K190802Envision ultrasound pad and coverITX2019-05-24
338081647373521K190802Envision ultrasound pad and coverITX2019-05-24
338081519383855K181007Cianna Medical SAVI Scout Reflector and SAVI Scout SystemNEU2018-08-02
338081695130570K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorITX2017-06-09
3350731695130570K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorITX2017-06-09
3350731491224970K160806Verza Guidance SystemITX2016-08-05
338081491224970K160806Verza Guidance SystemITX2016-08-05
338082020274909K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe ReprocessorPSW2015-11-16
3350732020274909K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe ReprocessorPSW2015-11-16
338081168534556K143396omni TRAX Active Patient TrackerIYO2015-01-23
3350731168534556K143396omni TRAX Active Patient TrackerIYO2015-01-23
3350732034582195K143333Revital-Ox RESERT Solution Test StripJOJ2015-04-14
1547731981324230K140490CIVA SHEET PD-103KXK2014-08-29
3350731154831626K131161EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,ITX2013-09-17
338081154831626K131161EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,ITX2013-09-17
3350731968831594K093713ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEMITX2010-01-19
338081968831594K093713ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEMITX2010-01-19
3350732073595055K092619ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKERIYO2009-11-13
338082073595055K092619ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKERIYO2009-11-13
3350731507423446K091022MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANTMED2010-04-12
1547732062511321K082159CIVASTRING PD-103KXK2008-09-30
3350731885808445K030064ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYITX2003-01-22
338081885808445K030064ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYITX2003-01-22
3350731285971794K013721SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVERITX2001-12-28
338081285971794K013721SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVERITX2001-12-28
1854611277236340
338081358417921
338081435327554
1854611668081937
338081808689023
338081836139176
338081906975656
3350731352298856
3350731358417921
3350731435327554
3350731544214867
3350731808689023
3350731836139176

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ITX272023-12-22
IYO112015-01-23
KXK32019-09-20
PSW22015-11-16
NEU12018-08-02
JOJ12015-04-14
MED12010-04-12
KKX11995-02-02

NDC#

116 records. Showing 1-40. Next

PMN#

VitroPRO

2023-11-14

CIVCO Medical Instruments Co., Inc.

VitroPRO

2022-11-22

CIVCO Medical Instruments Co., Inc.

CivaDerm

2019-09-20

CivaTech Oncology Inc.

41 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next