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Clinical Innovations, Inc.

USA · Murray

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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 17 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 1Class II 4

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

11 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

9active ARTG entries

Class I 2IVD Class 2 1IIa 5Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States17 registration records, 18 510(k), 0 PMA, 105 excluded

Brazil5 confirmed, 19 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada3 confirmed, 17 excluded

Manufacturer names merged into this page: CLINICAL INNOVATIONS, LLC · CLINICAL INNOVATIONS

FDA 510(k) clearances by year

11994

11996

11997

31998

12001

22003

12007

12011

22014

12015

12016

12023

22025

FDA listed device types

showing 8 of 15

Support, Patient Position 1Device, Intravascular Catheter Securement 1Immunoassay For Detection Of Amniotic Fluid Protein(S). 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Tape And Bandage, Adhesive 1Device, Cystometric, Hydraulic 1Monitor, Uterine Contraction, External (For Use In Clinic) 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250298	Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)	2025-10-08
US	K250897	Koala Intrauterine Pressure Catheter (IPC-5000E)	2025-05-22
US	K223900	babyLance Safety Heelstick (BLM, BLN, BLP)	2023-02-24
BR	10289680150	Adesivo retrator cirúrgico Traxi	Class I
BR	10289680141	EXTRATOR OBSTÉTRICO A VÁCUO DESCARTÁVEL KIWI®	Class II
BR	10289689014	Cateter balão duplo para tamponamento uterino Ebb - CTS -1000	Class II
CA	65203	SPIRAL FETAL SCALP ELECTRODE	Class II
CA	93436	KOALA TOCO	Class II
CA	100329	EBB COMPLETE TAMPONADE SYSTEM	Class II