Zoll Medical Corporation
⚠️ Moderate Risk
FEI: 2112020 • Deerfield, WI • UNITED STATES
FEI Number
2112020
Location
Deerfield, WI
Country
UNITED STATESAddress
500 Burdick Pkwy, , Deerfield, WI, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2020 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Northern Border Imports (DNBI) | |
| 3/5/2020 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Northern Border Imports (DNBI) | |
| 4/2/2018 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Northern Border Imports (DNBI) | |
| 5/14/2014 | 74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 6/11/2012 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Detroit District Office (DET-DO) | |
| 4/22/2003 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 476NO REGISTR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zoll Medical Corporation's FDA import refusal history?
Zoll Medical Corporation (FEI: 2112020) has 6 FDA import refusal record(s) in our database, spanning from 4/22/2003 to 3/5/2020.
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. Zoll Medical Corporation's FEI number is 2112020.
What types of violations has Zoll Medical Corporation received?
Zoll Medical Corporation has been cited for 6 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 Zoll Medical Corporation come from?
All FDA import refusal data for Zoll 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.