Reference Source

Dynamax · 89-08 · BRITISH VIRGIN ISLANDS

For Dynamax, import alert is 89-08; country is BRITISH VIRGIN ISLANDS; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Implantable Device | Implantable Device | Implantable Device; product code is 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic; date published is 06/20/2019; address is unknown , Unknown, BRITISH VIRGIN ISLANDS, verified against its source on 2026-09-30.

Firm
Dynamax verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
BRITISH VIRGIN ISLANDS verified
Address
unknown , Unknown, BRITISH VIRGIN ISLANDS verified
Date published
06/20/2019 verified
Product code
76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic each item verified
Product
Implantable Device | Implantable Device | Implantable Device each item verified
FDA notes
DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Dynamax Date Published : 06/20/2019 unknown , Unknown, BRITISH VIRGIN ISLANDS

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

76 - - - -- Dental Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 77 - - - -- Ear,Nose And Throat Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 87 - - - -- Orthopedic Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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