Medical Device Manufacturer · US , Parsippany , NJ

Rb Health (Us), LLC

14 submissions · 14 cleared · Since 2019
14
Total
14
Cleared
0
Denied

Rb Health (Us), LLC — FDA 510(k) Submissions

Rb Health (Us), LLC has submitted 14 FDA 510(k) premarket notifications since 2019, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lubricant, Personal, Condom, Condom, Synthetic . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Durex Polyisoprene Condom
K241617 · MOL Condom, Synthetic · Obstetrics & Gynecology
Feb 2025 268d
Belle Sensilube
K230781 · NUC Lubricant, Personal · Obstetrics & Gynecology
Jun 2023 90d
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
K213892 · NUC Lubricant, Personal · Obstetrics & Gynecology
Mar 2023 448d
Durex Patronus CloseFit, Durex Patronus Regular
K220489 · HIS Condom · Obstetrics & Gynecology
Nov 2022 258d
Durex Penck III Regular
K222068 · HIS Condom · Obstetrics & Gynecology
Oct 2022 90d
Durex Condom with Benzocaine
K211152 · HIS Condom · Obstetrics & Gynecology
May 2022 387d
Durex Patronus Wide
K213647 · HIS Condom · Obstetrics & Gynecology
Feb 2022 90d
Grosz Play Feel
K211088 · NUC Lubricant, Personal · Obstetrics & Gynecology
Jul 2021 88d
Durex Penck Standard, Durex Penck XL
K200672 · HIS Condom · Obstetrics & Gynecology
Nov 2020 238d
KY Grosz Jelly
K201186 · NUC Lubricant, Personal · Obstetrics & Gynecology
Jul 2020 90d
KY Grosz Liquid
K193032 · NUC Lubricant, Personal · Obstetrics & Gynecology
Apr 2020 172d
KY Grosz UltraGel
K192982 · NUC Lubricant, Personal · Obstetrics & Gynecology
Apr 2020 172d
KY Banksy Moisture
K183505 · NUC Lubricant, Personal · Obstetrics & Gynecology
May 2019 150d
KY Banksy Aloe
K183302 · NUC Lubricant, Personal · Obstetrics & Gynecology
Apr 2019 140d
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