510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ShenB Co., Ltd.

Seoul, KR

ShenB Co., Ltd. appears in FDA device records in Seoul, KR. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 10 510(k) clearances for ShenB Co., Ltd. between 2020 and 2026. The busiest year on record is 2021, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for ShenB Co., Ltd., by decision year
YearClearances
20201
20212
20221
20232
20241
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253926DiacoreNGXSubstantially Equivalent
K251649Sunny Plus (Sunny)NFOSubstantially Equivalent
K242241SunnyGEISubstantially Equivalent
K241535Vybe RF IIGEISubstantially Equivalent
K232223PlaDuo SystemGEISubstantially Equivalent
K230968VYBE RF Electrosurgical SystemGEISubstantially Equivalent
K221363AF LaserPDZSubstantially Equivalent
K211562Virtue RFGEISubstantially Equivalent
K202415VirtueRFGEISubstantially Equivalent
K201735PlaDuo SystemGEISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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

MDM coverage

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