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

South Natick, MA, US

Harvard Clinical Technology appears in FDA device records in South Natick, MA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
4
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Harvard Clinical Technology between 2003 and 2005. The busiest year on record is 2003, with 1. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for Harvard Clinical Technology, by decision year
YearClearances
20031
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K050107HARVARD 2 SYRINGE PUMP, MODEL 2001-001FRNSubstantially Equivalent
K033054HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMPMEASubstantially 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-0433-05Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001Potential pump motor/encoder assembly failure may cause over infusing medication in patientsTerminated
Z-0432-05Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001Potential pump motor/encoder assembly failure may cause over infusing medication in patientsTerminated
Z-0431-05Harvard 2 Dual Channel Syringe Infusion Pump P/N 2001-001Potential pump motor/encoder assembly failure may cause over infusing medication in patientsTerminated
Z-1208-03Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)Under specific sequence conditions, the unit may apper to be infusing, but is notTerminated

Verification record

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