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

Portola Valley, CA, US

Vivant Medical, Inc. appears in FDA device records in Portola Valley, CA. 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 Vivant Medical, Inc. between 2000 and 2005. The busiest year on record is 2003, with 4. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vivant Medical, Inc., by decision year
YearClearances
20002
20022
20034
20041
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K050223VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCERGEISubstantially Equivalent
K040279VIVARING MICROWAVE ABLATION PROBEGEISubstantially Equivalent
K032702VIVATIP MICROWAVE ABLATION PROBEGEISubstantially Equivalent
K032047TRI-LOOP MICROWAVE ABLATION PROBEGEISubstantially Equivalent
K031556VIVATHERM THEMPERATURE MEASUREMENT SYSTEMFLLSubstantially Equivalent
K023311LOOP MICROWAVE ABLATION PROBEGEISubstantially Equivalent
K022286ENCIRCLE LOCALIZATION DEVICEKNWSubstantially Equivalent
K011676VIVAWAVE MICROWAVE SYSTEMNEYSubstantially Equivalent
K003439VIVANT BREAST LESION LOCALIZATION DEVICEKNWSubstantially Equivalent
K000278VIVANT MEDICAL BIOPSY MARKER SYSTEMFZPSubstantially 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