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

Mchenry, IL, US

Nova Medical Specialties appears in FDA device records in Mchenry, IL. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Nova Medical Specialties between 1981 and 1987. The busiest year on record is 1984, with 5. The most recent is 1987, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nova Medical Specialties, by decision year
YearClearances
19811
19821
19831
19845
19862
19871
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K872770DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.DYGSubstantially Equivalent
K860526NOVA BALLOON THERMODILUTION PRESSURE TRANS CATHDXOSubstantially Equivalent
K853625NOVA ARTERIAL EMBOLECTOMY CATHETERDXESubstantially Equivalent
K840009NOVA 12 CARDIAC OUTPUT COMPUTERDXGSubstantially Equivalent
K841640NOVA BALLOON THERMODILUTION INFUSIONDYGSubstantially Equivalent
K841639NOVA BALLOON THERMODILUTION CATH.DYGSubstantially Equivalent
K834037HEPARIN COATED BALLOON THERMODILUDYGSubstantially Equivalent
K834036HEPARIN COATED BALLOON THERMODILUDYGSubstantially Equivalent
K832287NOVA BALLOON THERMODILUTION INFUSIONDYGSubstantially Equivalent
K822806BALLOON WEDGE PRESSURE, ANGIOGRAPHICDYGSubstantially Equivalent
K812761FLOW-DIRECTED BALLOON THERMODILUTIONKRGSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

MDM coverage

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Claiming lets Nova Medical Specialties edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Nova Medical Specialties. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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