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

Gunnison, UT, US

PROTEOR USA, Gunnison appears in FDA device records in Gunnison, UT. 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 PROTEOR USA, Gunnison 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.

  • Applied Composite Technologyrecall

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 PROTEOR USA, Gunnison, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30047372233004737223PROTEOR USA, Gunnison491 East 350 North, Gunnison, UT 84634 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-1149-2007VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.Terminated

Verification record

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