510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Tenet Medical Engineering

Calgary, CA

Tenet Medical Engineering appears in FDA device records in Calgary, CA. FDA records list 3 510(k) clearances between and , 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
3
PMA records
0
Recall records
3
Registered establishments
0

510(k) clearance history

FDA records hold 3 510(k) clearances for Tenet Medical Engineering between 1996 and 1997. The busiest year on record is 1997, with 2. The most recent is 1997, with 2.

Clearances by year, as a table
510(k) clearance decisions for Tenet Medical Engineering, by decision year
YearClearances
19961
19972
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K963505TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEMHHPSubstantially Equivalent
K963506TENET RADIOLUCENT HAND TABLEFQOSubstantially Equivalent
K964102TENET TIBIAL FRACTURE SUPPORTGBBSubstantially 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-0579-2008TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.Terminated
Z-0578-2008TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.Terminated
Z-0577-2008TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.Terminated

Verification record

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