510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Integra Radionics, Inc.

Burlington, MA, US

Integra Radionics, Inc. appears in FDA device records in Burlington, MA. FDA records list 10 510(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
10
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 10 510(k) clearances for Integra Radionics, Inc. between 2006 and 2011. The busiest year on record is 2006, with 2. The most recent is 2011, with 1.

Clearances by year, as a table
510(k) clearance decisions for Integra Radionics, Inc., by decision year
YearClearances
20062
20072
20081
20092
20102
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K102258CUSA NXT EXTENDED LENGTH TIPLFLSubstantially Equivalent
K100096LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHARTIYESubstantially Equivalent
K100417XKNIFE 5MUJSubstantially Equivalent
K090864CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFLSubstantially Equivalent
K083414RADIONICS XKNIFE HDRT SYSTEMMUJSubstantially Equivalent
K081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEMLFLSubstantially Equivalent
K072454INTEGRA RADIONICS INTERFIX PATIENT ADAPTERSIYESubstantially Equivalent
K071669INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIPLFLSubstantially Equivalent
K063230INTEGRA RADIONICS IMAGEFUSION 3MUJSubstantially Equivalent
K061893INTEGRA RADIONICS XKNIFE RT 4MUJSubstantially 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

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What MDM checks, and what it does not

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