ClearanceBrief
Company ยท US

Biofilm, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2022. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
NUCLubricant, Personal13
KMJLubricant, Patient2
HISCondom1
PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 1, 2022K221036Astroglide Warming
Biofilm, Inc.
NUC
May 26, 2022K220355Astroglide Ultra Gentle Gel
Biofilm, Inc.
NUC
May 6, 2022K220653Astroglide Glycerin & Paraben Free
Biofilm, Inc.
NUC
Mar 3, 2022K213671Astroglide Sensual Strawberry Personal Lubricant
Biofilm, Inc.
NUC
Apr 28, 2021K210242Astroglide X Silicone Personal Lubricant
Biofilm, Inc.
NUC
Nov 13, 2020K200239Astroglide Organix Gel
Biofilm, Inc.
NUC
Oct 13, 2020K200114Astroglide Organix Liquid
Biofilm, Inc.
NUC
Aug 30, 2017K171985Astroglide O Oil Personal Lubricant & Massage Oil
Biofilm, Inc.
NUC
Feb 10, 2017K163395Astroglide Diamond Silicone Gel Personal Lubricant
Biofilm, Inc.
NUC
Jan 9, 2015K141132ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
Biofilm, Inc.
PEB
Oct 30, 2014K140590ASTROGLIDE SENSUAL STRAWBERRY
Biofilm, Inc.
NUC
Aug 6, 2014K141581ASTROGLIDE NATURAL
Biofilm, Inc.
NUC
Jan 25, 2008K072647GLYCERIN & PARABEN FREE ASTROGLIDE
Biofilm, Inc.
NUC
Nov 30, 2004K041432ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
Biofilm, Inc.
HIS
Jan 24, 2003K020586GOOD LUBRICATIONS
Biofilm, Inc.
KMJ
Mar 9, 2001K003867EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
Biofilm, Inc.
NUC
Feb 18, 1994K935299ASTROGLIDE
Biofilm, Inc.
KMJ

Latest recalls

DateFirm and productCodeLinked 510(k)
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