Medical Device Manufacturer · US , Palo Alto , CA

Cardiogenes - FDA 510(k) Cleared Devices

20 submissions · 19 cleared · Since 1992

20

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiogenes General & Plastic Surgery ✕

20 devices

1-12 of 20

Cleared Jan 27, 1997

General & Plastic Surgery · 291d

Cleared Jan 17, 1996

General & Plastic Surgery · 77d

Cleared Sep 14, 1995

POWERSCULPTOR PROBES

General & Plastic Surgery · 91d

Cleared Aug 21, 1995

General & Plastic Surgery · 67d

Cleared Aug 11, 1995

General & Plastic Surgery · 39d

Cleared Jan 18, 1995

General & Plastic Surgery · 91d

Cleared Dec 27, 1994

SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT

General & Plastic Surgery · 95d

Cleared Nov 09, 1994

General & Plastic Surgery · 90d

Cleared Nov 01, 1994

OPTICAL FIBER FOR ENT APPLICATIONS

General & Plastic Surgery · 84d

Cleared Sep 20, 1994

CROSSFIRE(TM) (705-10650)

General & Plastic Surgery · 96d

Cleared Jul 22, 1994

General & Plastic Surgery · 15d

Cleared Jan 07, 1994

ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS

General & Plastic Surgery · 298d