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Medical Vision AB

Ne, MN, US

Medical Vision AB appears in FDA device records in Ne, MN. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

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

510(k) clearance history

FDA records hold 1 510(k) clearance for Medical Vision AB in 2010.

Clearances by year, as a table
510(k) clearance decisions for Medical Vision AB, by decision year
YearClearances
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K093409POWERPUMP ARTHROSCOPY SYSTEMHRXSubstantially 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-2705-2016Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.Sterility of device may be compromised due to sterile package breakage.Class IITerminated

Verification record

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