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Medtronic Powered Surgical Solutions

✅ Low Risk

FEI: 1625507 • Haltom City, TX • UNITED STATES

FEI

FEI Number

1625507

📍

Location

Haltom City, TX

🇺🇸
🏢

Address

4620 N Beach St, , Haltom City, TX, United States

Low Risk

FDA Import Risk Assessment

24.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
3
Unique Violations
4/15/2020
Latest Refusal
10/25/2001
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
1.6×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

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.

3411×

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).

Refusal History

DateProductViolationsDivision
4/15/2020
84HBCMOTOR, DRILL, ELECTRIC
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)
2/6/2013
84LBKDEVICE, NEUROSURGICAL FRAGMENTATION AND ASPIRATION
341REGISTERED
Florida District Office (FLA-DO)
10/25/2001
76DZADRILL, DENTAL, INTRAORAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Medtronic Powered Surgical Solutions's FDA import refusal history?

Medtronic Powered Surgical Solutions (FEI: 1625507) has 3 FDA import refusal record(s) in our database, spanning from 10/25/2001 to 4/15/2020.

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. Medtronic Powered Surgical Solutions's FEI number is 1625507.

What types of violations has Medtronic Powered Surgical Solutions received?

Medtronic Powered Surgical Solutions has been cited for 3 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 Medtronic Powered Surgical Solutions come from?

All FDA import refusal data for Medtronic Powered Surgical Solutions 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.