Atom Medical Corporation

⚠️ Moderate Risk

FEI: 3005652389 • Bunkyo, Tokyo • JAPAN

FEI

FEI Number

3005652389

📍

Location

Bunkyo, Tokyo

🇯🇵

Country

JAPAN

🏢

Address

3 Chome 18-15, Hongo, Bunkyo, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

30.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

1/17/2020

Latest Refusal

3/21/2002

Earliest Refusal

Score Breakdown

Violation Severity

48.8×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

4.5×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

3417×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5086×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

Date	Product	Violations	Division
1/17/2020	80FOXSTAND, INFUSION	118NOT LISTED 3280FRNMFGREG	Division of West Coast Imports (DWCI)
4/3/2014	95RIAHIGH INTENSITY LAMP	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
8/25/2008	73CAFNEBULIZER (DIRECT PATIENT INTERFACE)	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/31/2004	80FMZINCUBATOR, NEONATAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/2/2002	80FPLINCUBATOR, NEONATAL TRANSPORT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
8/2/2002	80FPLINCUBATOR, NEONATAL TRANSPORT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/21/2002	74DSFRECORDER, PAPER CHART	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/21/2002	74DSFRECORDER, PAPER CHART	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Atom Medical Corporation's FDA import refusal history?

Atom Medical Corporation (FEI: 3005652389) has 8 FDA import refusal record(s) in our database, spanning from 3/21/2002 to 1/17/2020.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Atom Medical Corporation's FEI number is 3005652389.

What types of violations has Atom Medical Corporation received?

Atom Medical Corporation has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Atom Medical Corporation come from?

All FDA import refusal data for Atom Medical Corporation is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.