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Data / Medical devices / United States / Veridian Healthcare

Veridian Healthcare: FDA-registered device maker in Gurnee, IL, United States, 19 510(k) clearances

Veridian Healthcare is registered with the FDA (registration 3007499349) in Gurnee, IL, United States. It lists 16 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 1, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3007499349
FEI number
3011774813
Address
1175 Lakeside Dr, Gurnee, IL, United States, 60031
Owner or operator
Veridian Healthcare (10028759)
Roles
Repackager or relabeler
First device listed
September 6, 2023
Registered through
2026
Brand names listed
01-508 SmartHeart Automatic Wrist Digital BP, 01-517 SmartHeart Automatic Wrist Blood Pressure Monitor with Large Display, 01-539 SmartHeart Auto Digital Blood Pressure Monitor, 01-539WR SmartHeart Auto Digital BP Monitor, Wide Range Cuff, 01-540 SmartHeart Wrist Blood Pressure Monitor, 01-550 SmartHeart Automatic Arm Digital BP, 01-553 SmartHeart Automatic DBPM-Wide Range Cuff, 01-556 SmartHeart Automatic Wrist Digital BP and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 1, 2026K260276Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S ProDXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
May 2, 2025K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist BlooDXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
April 30, 2025K244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);DXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
November 15, 2024K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)QRLSubstantially EquivalentTianjin Huahong Technology Co., Ltd.accessdata.fda.gov
August 21, 2024K241351Blood Pressure Monitor (TMB-2092-G)DXNSubstantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.accessdata.fda.gov
December 20, 2023K233130Blood Pressure MonitorDXNSubstantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.accessdata.fda.gov
November 28, 2023K232713Blood Pressure MonitorDXNSubstantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.accessdata.fda.gov
June 28, 2023K223722MIO Blood Glucose Monitoring SystemNBWSubstantially EquivalentMio Labs, Inc.accessdata.fda.gov
December 1, 2022K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GDXNSubstantially EquivalentShenzhen AOJ Medical Technology Co., Ltd.accessdata.fda.gov
December 19, 2018K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring SystemNBWSubstantially EquivalentVivachek Laboratories, Inc.accessdata.fda.gov
February 10, 2012K112042KINGYIELD WRIST BLOOD PRESSURE MONITORDXNSubstantially EquivalentShenzhen Kingyield Technology Co., Ltd.accessdata.fda.gov
January 31, 2012K120058TRANSTEK BLOOD PRESSURE MONITORDXNSubstantially EquivalentZhongshan Transtek Electronics Co., Ltd.accessdata.fda.gov
December 16, 2010K102624AVITA WRIST TYPE BLOOD PRESSURE MONITORDXNSubstantially EquivalentAvita Corporationaccessdata.fda.gov
November 24, 2010K102690FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
October 29, 2010K102906FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORDXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
November 10, 2009K091272BESMED JET NEBULIZER BOTTLE SETCAFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
July 30, 2009K092045FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739DXNSubstantially EquivalentAndon Health Co, Ltd.accessdata.fda.gov
March 23, 2007K062033BP 101 DIGITAL BLOOD PRESSURE MONITORDXNSubstantially EquivalentKingyield Hongkong Limitedaccessdata.fda.gov
January 14, 2000K984551INFRARED EAR THERMOMETER, MODEL KI-8120FLLSubstantially EquivalentK-Jump Health Co., Ltd.accessdata.fda.gov

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Updated April 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.