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

Grafton, WI, US

GAUTHIER BIOMEDICAL, INC. appears in FDA device records in Grafton, WI. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Gauthier Biomedical, Inc. in 2018.

Clearances by year, as a table
510(k) clearance decisions for Gauthier Biomedical, Inc., by decision year
YearClearances
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K180092IntellitorqHXCSubstantially Equivalent

Registered establishments

FDA registered establishments for Gauthier Biomedical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21349473010938185GAUTHIER BIOMEDICAL, INC.2221 Washington St, Grafton, WI 53024 US2026and 41 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-0572-2025TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)An out of specification component may result in the device exhibiting torque output higher than the design specification.Class IIOpen, Classified

Verification record

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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