Medical Device Manufacturer · US , Waltham , MA

Astra Tech, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1994

Recent clearances: LOFRIC PRIMO, LOFRIC HYDRO-KIT, ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA, ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Astra Tech, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Oct 31, 2012

LOFRIC PRIMO, LOFRIC HYDRO-KIT

Gastroenterology & Urology · 107d

Cleared May 05, 2005

ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER

Gastroenterology & Urology · 29d

Cleared Dec 23, 2004

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

Gastroenterology & Urology · 30d

Cleared Aug 23, 2001

MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER

Gastroenterology & Urology · 28d