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

Shizuoka-Ken, JP

NIKKISO CO., LTD. - SHIZUOKA PLANT appears in FDA device records in Shizuoka-Ken, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

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

FDA records under these names

1 name

FDA records resolved to Nikkiso Co., Ltd. - Shizuoka Plant carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Nikkiso Ltd - Shizuoka Plantenforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Nikkiso Co., Ltd. - Shizuoka Plant, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80315613002807721NIKKISO CO., LTD. - SHIZUOKA PLANT498-1 SHIZUTANI, SHIZUOKA-KEN 421-0496 JP2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0456-2022DBB-06 Hemodialysis Delivery SystemDevice lacks premarket approval.Class IIOpen, Classified

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