Civco Medical Instruments Co Inc

FDA Filings

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

FDA Registration(s)
Registration Number1937223
FEI Number1937223
NameCIVCO Medical Instruments Co., Inc.
Owner & OperatorCIVCO Medical Instruments Co., Inc.
Contact Address102 FIRST ST. SOUTH --
Kalona IA 52247 US
Official Correspondent
  • JIM - LEONG
  • x-319-6564447-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address102 FIRST ST. SOUTH
Kalona, IA 52247 US
Establishment Type
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 639-0722024-09-17
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 644-1052024-09-17
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-21592024-09-17
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide Bracket 676-2432024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 653-0062024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 610-15562024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 610-15542024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 610-15532024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 810-401, 810-401-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 810-400, 810-400-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 867-005, 867-005-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 842-004, 842-004-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 842-002, 842-002-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 880-001, 880-001-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 876-001, 867-001-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 867-003, 867-003-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 867-001, 867-001-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 857-001, 857-001-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 844-001, 844-001-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 842-001, 842-001-52024-06-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 657-1042024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 657-1022024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 680-1852024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 657-1002024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 639-0682024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide Bracket 693-0142024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide Bracket 693-0122024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 610-15552024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-016TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-015TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-0242024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-0232024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-0222024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-0212024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-020TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-019TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-018TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-017TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-010TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-009TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-004TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover H2O-005TR2024-02-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
eTRAX™ Needle System Starter Kit 610-12542023-05-16
CIVCO MEDICAL INSTRUMENTS CO., INC.
UltrOx 610-24732023-05-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
UltrOx 610-24722023-05-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
HLD Starter Kit 610-24742023-05-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 610-15512023-05-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 610-15502023-05-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 11575442, 11575442-52023-05-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 116529612023-05-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 658-0052023-02-13
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 644-102, 644-102-52023-02-13
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 644-1012023-02-13
CIVCO MEDICAL INSTRUMENTS CO., INC.
NeedleGuide H44901AX, H44901AX-52022-12-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
NeedleGuide H44901AW2022-12-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide Starter Kit 671-0032022-11-30
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide H44901AY2022-11-30
CIVCO Medical Instruments Co., Inc.
VitroPRO2022-11-22
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 639-0632022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 639-0612022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide Bracket 687-0042022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide Bracket 687-0022022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
CAB-VR™ Storage System 610-2420A2022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
CAB-TEE Storage System 610-2419A2022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
VirtuTRAX Instrument Navigator 620-1272022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 115043402022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Multi-Purpose Workstation ™ Stepper 610-13592022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
EX3™ Stepper 658-0072022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 11506901, 11506901-52022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Cradle 658-0062022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 11504339, 11504339-52022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 676-2252022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Cradle 610-13582022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 676-1942022-11-07
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 657-0952022-07-29
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Starter Kit DLX-200-NGB2022-07-29
CIVCO MEDICAL INSTRUMENTS CO., INC.
Tracking Bracket 657-0872022-05-09
CIVCO MEDICAL INSTRUMENTS CO., INC.
Tracking Bracket Starter Kit 657-0862022-05-09
CIVCO MEDICAL INSTRUMENTS CO., INC.
Verza Guidance System 115043412022-05-05
CIVCO MEDICAL INSTRUMENTS CO., INC.
Verza Guidance System 115041062022-05-05
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 670-0372022-04-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
Biopsy Bracket 657-0512022-04-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIV-Flex™ Transducer Cover 610-16002022-02-17
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-8502022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-7202022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-21742022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-21732022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-21652022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-21632022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-21442022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-9212022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
GUS 610-21682022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover 610-24622022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
Disinfecting Container 610-7232022-02-04
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover 610-23962021-12-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover 610-24252021-12-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
Transducer Cover 610-24242021-12-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIV-Flex™ Transducer Cover 610-23272021-11-29
CIVCO MEDICAL INSTRUMENTS CO., INC.
Tracking Bracket 676-2202021-11-29
CIVCO MEDICAL INSTRUMENTS CO., INC.
Needle Guide 610-14312021-11-29
CIVCO MEDICAL INSTRUMENTS CO., INC.
Multi-Purpose Workstation ™ Stepper 7700-22021-11-29
CIVCO Medical Instruments Co., Inc.
CIV-Clear Cover2021-09-13
CIVCO Medical Instruments Co., Inc.
SCOUT Surgical Guidance System2019-11-18
CIVCO Medical Instruments Co., Inc.
Envision2019-05-24
CIVCO Medical Instruments Co., Inc.
Astra VR2017-12-19
CIVCO Medical Instruments Co., Inc.
Astra TEE2017-12-19
CIVCO MEDICAL INSTRUMENTS CO., INC.
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor2017-06-09
CIVCO Medical Instruments Co., Inc.
GUS ASTRA VR Endovaginal/Endorectal Probe Reprocesor2016-11-21
CIVCO Medical Instruments Co., Inc.
GUS ASTRA TEE Transesophageal Probe Reprocessor2016-11-21
CIVCO Medical Instruments Co., Inc.
VR Storage Cabinet2016-11-21
CIVCO Medical Instruments Co., Inc.
TEE Storage Cabinet2016-11-21
CIVCO Medical Instruments Co., Inc.
Verza Needle Guide2016-09-22
CIVCO MEDICAL INSTRUMENTS CO., INC.
Verza Guidance System2016-08-05
CIVCO Medical Instruments Co., Inc.
Endocavity Transducer Soaking System2016-05-12
CIVCO Medical Instruments Co., Inc.
omniTRAX(TM) Active Patient Tracker2015-02-03
CIVCO Medical Instruments Co., Inc.
omniTRAX(TM) Active Patient Tracker2015-02-03
CIVCO Medical Instruments Co Inc Dba CIVCO Medical Solutions
Omni TRAX Active Patient Tracker2015-01-23
CIVCO Medical Instruments Co., Inc.
RAD guide2014-04-08
CIVCO Medical Instruments Co., Inc.
CT Extension Handle2014-04-08
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation LP2013-12-17
CIVCO Medical Instruments Co., Inc.
Micro-Touch2013-12-17
CIVCO Medical Instruments Co., Inc.
Micro-Touch LP2013-12-17
CIVCO Medical Instruments Co., Inc.
EX3 Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Disposable Template Grid2013-12-17
CIVCO Medical Instruments Co., Inc.
Classic Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation LP2013-12-17
CIVCO Medical Instruments Co., Inc.
Micro-Touch2013-12-17
CIVCO Medical Instruments Co., Inc.
Micro-Touch LP2013-12-17
CIVCO Medical Instruments Co., Inc.
EX3 Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Disposable Template Grid2013-12-17
CIVCO Medical Instruments Co., Inc.
Classic Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Multi-Purpose Workstation LP2013-12-17
CIVCO Medical Instruments Co., Inc.
Micro-Touch2013-12-17
CIVCO Medical Instruments Co., Inc.
Micro-Touch LP2013-12-17
CIVCO Medical Instruments Co., Inc.
EX3 Stepper2013-12-17
CIVCO Medical Instruments Co., Inc.
Disposable Template Grid2013-12-17
CIVCO Medical Instruments Co., Inc.
Classic Stepper2013-12-17
CIVCO MEDICAL INSTRUMENTS CO., INC.
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,2013-09-17
CIVCO MEDICAL INSTRUMENTS CO., INC.
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER2013-06-11
CIVCO Medical Instruments Co., Inc.
Ultra-Pro II2010-11-15
CIVCO Medical Instruments Co., Inc.
Ultra-Pro 32010-11-15
CIVCO Medical Instruments Co., Inc.
Multi-Pro 20002010-11-15
CIVCO Medical Instruments Co., Inc.
Maggi II Plus2010-11-15
CIVCO Medical Instruments Co., Inc.
Infinity2010-11-15
CIVCO Medical Instruments Co., Inc.
AccuSITE2010-11-15
CIVCO Medical Instruments Co., Inc.
Needle Guide Template2009-11-16
CIVCO Medical Instruments Co., Inc.
Brachystepper2009-11-16
CIVCO Medical Instruments Co., Inc.
Brachystand2009-11-16
CIVCO Medical Instruments Co., Inc.
PROcover2009-11-16
CIVCO Medical Instruments Co., Inc.
Surgi cover2009-11-16
CIVCO Medical Instruments Co., Inc.
Transrectal Guide2009-11-16
CIVCO Medical Instruments Co., Inc.
eTRAX Variable Angle Needle Guide2009-11-16
CIVCO Medical Instruments Co., Inc.
eTRAX Needle System2009-11-16
CIVCO Medical Instruments Co., Inc.
ViruTRAX Instrument Navigator2009-11-16
CIVCO Medical Instruments Co., Inc.
General Purpose Sensor2009-11-16
CIVCO Medical Instruments Co., Inc.
EMT System2009-11-16
CIVCO Medical Instruments Co., Inc.
Active Fiducial Marker2009-11-16
CIVCO Medical Instruments Co., Inc.
Neoguard2009-11-16
CIVCO Medical Instruments Co., Inc.
L25 series needle guide2009-09-09
CIVCO Medical Instruments Co., Inc.
Brachyballoon standoff2009-07-06
CIVCO MEDICAL INSTRUMENTS CO., INC.
MRI PATIENT POSITIONING DEVICES2008-06-04
CIVCO Medical Instruments Co., Inc.
MULTI-PURPOSE HOLDER2005-07-26
CIVCO Medical Instruments Co., Inc.
CIVCO ASSIST POSITIONING ARM SYSTEM2005-07-26
CIVCO MEDICAL INSTRUMENTS CO., INC.
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER2001-12-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE2000-10-31
CIVCO MEDICAL INSTRUMENTS CO., INC.
GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF1999-08-17
CIVCO MEDICAL INSTRUMENTS CO., INC.
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,1999-06-02
CIVCO MEDICAL INSTRUMENTS CO., INC.
GENERAL PURPOSE LATEX TRANSDUCER COVERS1997-06-20
CIVCO MEDICAL INSTRUMENTS CO., INC.
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE1997-06-20
CIVCO MEDICAL INSTRUMENTS CO., INC.
GENERAL PURPOSE TRANDUCER COVER1997-06-20
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO PROBE BOOT/CORD COVER1995-02-02
CIVCO MEDICAL INSTRUMENTS CO., INC.
TRANS/R - FP(3)1990-06-11
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO LATEX ULTRASOUND SHEATHS1989-12-14
CIVCO Medical Instruments Co., Inc.
TRANSDUCER COVER1989-09-14
CIVCO Medical Instruments Co., Inc.
CIVCO ULTRASOUND SNEATH1989-09-14
CIVCO Medical Instruments Co., Inc.
TRANSDUCER COVER1989-09-14
CIVCO Medical Instruments Co., Inc.
STANDOFF BALLOON1989-09-14
CIVCO Medical Instruments Co., Inc.
CIVCO ULTRASOUND TRANSDUCER SHEATH1989-09-14
CIVCO MEDICAL INSTRUMENTS CO., INC.
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES1988-11-28
CIVCO MEDICAL INSTRUMENTS CO., INC.
TRANS/V NEEDLE GUIDE1988-04-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
TRANS/P NEEDLE GUIDE1988-04-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
TRANS/R NEEDLE GUIDE1988-04-15
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO SEED IMPLANT NEEDLE GUIDE1988-04-14
CIVCO Medical Instruments Co., Inc.
TRANSVAGINAL BIOPSY GUIDE1987-08-13
CIVCO Medical Instruments Co., Inc.
TRANSPERINCAL1987-08-13
CIVCO Medical Instruments Co., Inc.
MAGGI1987-08-13
CIVCO Medical Instruments Co., Inc.
CIVCO ENDOCAVITY ULTRASOUND1987-08-13
CIVCO Medical Instruments Co., Inc.
TRANSVAGINAL BIOPSY GUIDE1987-08-13
CIVCO Medical Instruments Co., Inc.
TRANSPERINCAL1987-08-13
CIVCO Medical Instruments Co., Inc.
MAGGI1987-08-13
CIVCO Medical Instruments Co., Inc.
CIVCO ENDOCAVITY ULTRASOUND1987-08-13
CIVCO Medical Instruments Co., Inc.
TRANSVAGINAL BIOPSY GUIDE1987-08-13
CIVCO Medical Instruments Co., Inc.
TRANSPERINCAL1987-08-13
CIVCO Medical Instruments Co., Inc.
MAGGI1987-08-13
CIVCO Medical Instruments Co., Inc.
CIVCO ENDOCAVITY ULTRASOUND1987-08-13
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO STEPPER1987-07-14
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE1986-07-23
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO SCAN DRAPE1985-01-23
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO-SUPER SCAN/BIOPSY GUIDE1984-12-13
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO/SUPER SCAN1984-05-09
CIVCO MEDICAL INSTRUMENTS CO., INC.
RNG SERIES ULTRASOUND NEEDLE/CATH. GDS1982-03-23

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