Home›USA›CIVCO Medical Instruments Co., Inc.

CIVCO Medical Instruments Co., Inc.

USA · Coralville

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 5Class II 10Class III 0

plus 29 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

28registered devices

Class I 24Class II 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

19registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 4

21 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States29 registration records, 31 510(k), 0 PMA, 7 excluded

Brazil28 confirmed, 3 excluded

Saudi Arabia19 confirmed, 2 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: CIVCO Medical Instruments Co., Inc. · CIVCO MEDICAL INSTRUMENTS CO., INC. DBA CIVCO AND CIVCO MEDICAL SOLUTIONS · CIVCO MEDICAL INSTRUMENTS CO.,INC. · CIVCO MEDICAL INSTRUMENTS · Civco Medical Instruments, Inc. · CIVCO Medical Instruments Co., Inc DBA CIVCO and CIVCO Medical Solutions

Same-named companies — This database also contains companies with near-identical names: CIVCO MEDICAL INSTRUMENTS CO., INC. DBA CIVCO AND CIVCO MEDICAL SOLUTIONS, Civco Medical Instruments CO Inc Dba Civco Medical Solutions. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11985

11986

11987

51988

11989

11990

11995

31997

21999

12000

12001

12008

12010

22013

12015

12016

12017

12021

12022

12023

FDA listed device types

showing 8 of 15

Needle, Assisted Reproduction 1System, Applicator, Radionuclide, Remote-Controlled 1Lamp, Infrared, Therapeutic Heating 1High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid 1Indicator, Physical/Chemical Sterilization Process 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Nuclear Magnetic Resonance Imaging 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231783	VitroPRO	2023-11-14
US	K222052	VitroPRO	2022-11-22
US	K211270	CIV-Clear cover	2021-09-13
BR	10337850105	Guia de Agulha AccuSITE	Class I
BR	10337850130	Capa Protetora PeelSafe Advantage	Class I
BR	10337859028	KIT CANULA TRANSPERINEAL TP PIVOT PRO COM ADAPTADOR	Class II
SA	ME0000006496SFDAA00050	Micro-Touch® Stabilizer LP	—
SA	ME0000006496SFDAA00050	Micro-Touch® Stabilizer LP	—
CA	21392	NEO-FLEX (POLYCHLOROPRENE) LATEX-FREE ULTRASOUND TRANSDUCER COVER	Class II
CA	72660	COLLECTEVAC	Class II
CA	100156	INTUIT TRANSDUCER COVER WITH PEELSAFE ADVANTAGE	Class II

CIVCO Medical Instruments Co., Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies