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Biologic Therapies, Inc.

Prior Lake, MN, US

Biologic Therapies, Inc. appears in FDA device records in Prior Lake, MN. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Biologic Therapies, Inc. in 2015.

Clearances by year, as a table
510(k) clearance decisions for Biologic Therapies, Inc., by decision year
YearClearances
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K141910Intraosseous Cannula System Bio-MAC¿ and Bio-COREKNWSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1374-2015Bio-CORE Cannula (Needle) SetDevices are misbranded - failure to properly classify and obtain FDA clearance prior distributionClass IITerminated
Z-1373-2015Bio-MAC Cannula (Needle) SetDevices are misbranded - failure to properly classify and obtain FDA clearance prior distributionClass IITerminated
Z-1372-2015Bio-PLASTY Cannula (Needle)Devices are misbranded - failure to properly classify and obtain FDA clearance prior distributionClass IITerminated

Verification record

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