510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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TOMY International

Canton, MA, US

TOMY International appears in FDA device records in Canton, MA. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
7
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to TOMY International 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.

  • RC2 Brands Inc., The First Yearsrecall

510(k) clearance history

FDA records hold 1 510(k) clearance for TOMY International in 2013.

Clearances by year, as a table
510(k) clearance decisions for TOMY International, by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K131027MEMORY PUMP MODEL Y4947HGXSubstantially Equivalent

Registered establishments

FDA registered establishments for TOMY International, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30068524573006852457TOMY International2021 9TH ST. S.E., Dyersville, IA 52040 US2026
12178051217805TOMY International, Inc.45 Shawmut Rd, Canton, MA 02021 US2026and 5 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-0766-2023Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288LAffected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.Class IIOpen, Classified
Z-0460-06Sesame Beginnings Chill & Chew Teether Style #Y3095Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putidaTerminated
Z-0459-06The First Years Floating Friend Teether Style #Y1474Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putidaTerminated
Z-0458-06The First Years Cool Animal Teether/Fish, Zebra and Dinosaur designs Style #Y1473Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putidaTerminated
Z-0457-06Disney Baby Soft Cool Ring Teether Style # Y1490Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putidaTerminated
Z-0456-06Disney Baby Soft Cool Ring Teether Style # Y1470Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putidaTerminated
Z-0455-06Disney Days Hunny Cool Ring Teether Style # Y1447Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putidaTerminated

Verification record

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