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

Palo Alto, CA, US

Cardiogenes appears in FDA device records in Palo Alto, CA. FDA records list 20 510(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
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for Cardiogenes between 1992 and 1997. The busiest year on record is 1993, with 6. The most recent is 1997, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cardiogenes, by decision year
YearClearances
19922
19936
19946
19954
19961
19971
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K961560ECLIPSE 2000GEXSubstantially Equivalent
K955006ECLIPSE 2100GEXSubstantially Equivalent
K952755POWERSCULPTOR PROBESGEXSubstantially Equivalent
K953658CORSSFIRE PLUSGEXSubstantially Equivalent
K953424ECLIPSE 3200GEXSubstantially Equivalent
K945126ECLIPSE 3200GEXSubstantially Equivalent
K944758SUNRISE TECHNOLOGIES MODEL 5020 PLDD KITGEXUnknown
K944153ECLIPSE 3200GEXSubstantially Equivalent
K944151OPTICAL FIBER FOR ENT APPLICATIONSGEXSubstantially Equivalent
K943171CROSSFIRE(TM) (705-10650)GEXSubstantially Equivalent
K943311ECLIPSE 3200GEXSubstantially Equivalent
K931305ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONSGEXSubstantially Equivalent
K934935ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEMGEXSubstantially Equivalent
K931101ECLIPSE 2100(TM) MODEL 32, MODIFICATIONGEXSubstantially Equivalent
K926210ECLIPSE 3200GEXSubstantially Equivalent
K931306ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINTGEXSubstantially Equivalent
K925840ECLIPSE 3200GEXSubstantially Equivalent
K924943ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMYGEXSubstantially Equivalent
K924214ECLIPSE 2100(TM) MODEL 32GEXSubstantially Equivalent
K921038ECLIPSE 2100GEXSubstantially 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