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

Rancho Cucamonga, CA, US

MYOFUNCTIONAL RESEARCH CO. USA appears in FDA device records in Rancho Cucamonga, CA. 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 Myofunctional Research Co. USA 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.

  • Myofunctional Research Company USAenforcement 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 Myofunctional Research Co. USA, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30055056033005505603MYOFUNCTIONAL RESEARCH CO. USA9267 Charles Smith Ave, Rancho Cucamonga, CA 91730 US2026

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-0956-2026Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.Class IIOpen, Classified

Verification record

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