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

Union City, CA, US

MIZUHO AMERICA, INC. appears in FDA device records in Union City, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
4
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Mizuho America, Inc. between 1996 and 2022. The busiest year on record is 2022, with 2. The most recent is 2022, with 2.

Clearances by year, as a table
510(k) clearance decisions for Mizuho America, Inc., by decision year
YearClearances
19961
19971
19991
20222
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K221524Sugita AVM Microclip ApplierHCISubstantially Equivalent
K211183Sugita AVM MicroclipsHCHSubstantially Equivalent
K990202SUGITA TITANIUM ANEURYSM CLIPHCHSubstantially Equivalent
K960037SUGITA AVM MICROCLIPHCHSubstantially Equivalent
K955012MIZUHO RADIOLUCENT HEAD FRAMEHBLSubstantially Equivalent

Registered establishments

FDA registered establishments for Mizuho America, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12236561000159388MIZUHO AMERICA, INC.30057 Ahern Ave, Union City, CA 94587 US2026and 3 more, listed in full below

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-0567-2021Microsurgical Operating Room Tables;7300BX (18-351-70).Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.Class IIOpen, Classified
Z-0566-2021Microsurgical Operating Room Tables;7300B (18-350-70);Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.Class IIOpen, Classified
Z-0378-2014Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.Class IITerminated
Z-0377-2014Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.Class IITerminated

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