510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dyne Medical Group Inc.

Gimpo- si Gyeonggi, KR

DYNE MEDICAL GROUP INC. appears in FDA device records in Gimpo- si Gyeonggi, KR. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Dyne Medical Group Inc. between 2024 and 2026. The busiest year on record is 2024, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dyne Medical Group Inc., by decision year
YearClearances
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252933DYNE PORTODCSubstantially Equivalent
K240203URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)FGBSubstantially Equivalent

Registered establishments

FDA registered establishments for Dyne Medical Group Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30325788463032578846DYNE MEDICAL GROUP INC.#1001-1013, #1015-1016, #1024-1025, 10F, 165, Gimpohangang 10-ro 133beon-gil,, Gimpo- si Gyeonggi 10071 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain