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

Fremont, CA, US

Vidamed, Inc. appears in FDA device records in Fremont, CA. 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 Vidamed, Inc. between 1995 and 2002. The busiest year on record is 1997, with 3. The most recent is 2002, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vidamed, Inc., by decision year
YearClearances
19952
19962
19973
20013
20021
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K014224PRECISION PLUS TUNA OFFICE SYSTEMGEISubstantially Equivalent
K012587RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPEKNSSubstantially Equivalent
K011787PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPEKNSSubstantially Equivalent
K002583TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEMKNSSubstantially Equivalent
K973366COBRA HAND PIECEKNSSubstantially Equivalent
K965199TUNA 5 CATHETERGEISubstantially Equivalent
K965061VIDAMED MODEDL 7600 RF GENERATORGEISubstantially Equivalent
K963180VIDAMED RF GENERATOR DATA RECORDERGEISubstantially Equivalent
K960918VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEMGEISubstantially Equivalent
K955035VIDAMED SERIES 7205 ELECTROSURGICAL GENERATORGEISubstantially Equivalent
K951245VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORYGEISubstantially 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

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