ZOLL Medical Corporation
⚠️ Moderate Risk
FEI: 1220908 • Chelmsford, MA • UNITED STATES
FEI Number
1220908
Location
Chelmsford, MA
Country
UNITED STATESAddress
269 Mill Rd, , Chelmsford, MA, 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).
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).
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2024 | 73BTLVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) | Division of Southwest Imports (DSWI) | |
| 10/26/2021 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 3/2/2021 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/22/2020 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | Division of West Coast Imports (DWCI) | |
| 1/2/2019 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | Division of West Coast Imports (DWCI) | |
| 2/26/2018 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Division of Southeast Imports (DSEI) | |
| 5/18/2015 | 73BTLVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) | 341REGISTERED | Seattle District Office (SEA-DO) |
| 3/6/2014 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | New England District Office (NWE-DO) | |
| 6/25/2013 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 1/6/2010 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/18/2007 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | Chicago District Office (CHI-DO) | |
| 5/25/2006 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | 341REGISTERED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is ZOLL Medical Corporation's FDA import refusal history?
ZOLL Medical Corporation (FEI: 1220908) has 12 FDA import refusal record(s) in our database, spanning from 5/25/2006 to 11/13/2024.
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 1220908.
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.