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

Siheung-si Gyeonggi, KR

T&R BIOFAB CO.,LTD. appears in FDA device records in Siheung-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 T&R Biofab Co.,Ltd. between 2023 and 2026. The busiest year on record is 2023, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for T&R Biofab Co.,Ltd., by decision year
YearClearances
20231
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251959TnR Cranial ImplantGXPSubstantially Equivalent
K222057THERMOCLICKFLLSubstantially Equivalent

Registered establishments

FDA registered establishments for T&R Biofab Co.,Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30169010803016901080T&R BIOFAB CO.,LTD.96, Mayu-ro, Siheung-si Gyeonggi 15111 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

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