Medical Device Manufacturer · US , Vista , CA

Biofilm, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1994
17
Total
17
Cleared
0
Denied

FDA 510(k) cleared devices by Biofilm, Inc. Obstetrics & Gynecology

15 devices
1-15 of 15
Cleared Jul 01, 2022
Astroglide Warming
K221036 · NUC
Obstetrics & Gynecology · 85d
Cleared May 26, 2022
Astroglide Ultra Gentle Gel
K220355 · NUC
Obstetrics & Gynecology · 107d
Cleared May 06, 2022
Astroglide Glycerin & Paraben Free
K220653 · NUC
Obstetrics & Gynecology · 60d
Cleared Mar 03, 2022
Astroglide Sensual Strawberry Personal Lubricant
K213671 · NUC
Obstetrics & Gynecology · 101d
Cleared Apr 28, 2021
Astroglide X Silicone Personal Lubricant
K210242 · NUC
Obstetrics & Gynecology · 89d
Cleared Nov 13, 2020
Astroglide Organix Gel
K200239 · NUC
Obstetrics & Gynecology · 287d
Cleared Oct 13, 2020
Astroglide Organix Liquid
K200114 · NUC
Obstetrics & Gynecology · 266d
Cleared Aug 30, 2017
Astroglide O Oil Personal Lubricant & Massage Oil
K171985 · NUC
Obstetrics & Gynecology · 58d
Cleared Feb 10, 2017
Astroglide Diamond Silicone Gel Personal Lubricant
K163395 · NUC
Obstetrics & Gynecology · 67d
Cleared Jan 09, 2015
ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
K141132 · PEB
Obstetrics & Gynecology · 253d
Cleared Oct 30, 2014
ASTROGLIDE SENSUAL STRAWBERRY
K140590 · NUC
Obstetrics & Gynecology · 237d
Cleared Aug 06, 2014
ASTROGLIDE NATURAL
K141581 · NUC
Obstetrics & Gynecology · 54d
Cleared Jan 25, 2008
GLYCERIN & PARABEN FREE ASTROGLIDE
K072647 · NUC
Obstetrics & Gynecology · 128d
Cleared Nov 30, 2004
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · HIS
Obstetrics & Gynecology · 186d
Cleared Mar 09, 2001
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC...
K003867 · NUC
Obstetrics & Gynecology · 87d
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