Ortho Pharmaceutical Corp.
United StatesFDA applicant, unverified
- Devices
- 9
What Ortho Pharmaceutical Corp. makes
Ortho Pharmaceutical Corp. manufactures personal lubricants, including K-Y Personal Lubricant and a generic lubricant product, as well as home pregnancy tests such as the Advance Pregnancy Test and Fact Home Pregnancy Test. Their portfolio also includes a pulsatile pump for gonadotropin acetate, a selective culture medium for medical use, and a device called the Microscrape. Additionally, they produce prophylactic contraceptive products under the Conceptrol/Thin brand.
The company’s devices are classified under FDA categories Class I and Class II, with several listed via the 510(k) pathway. These products are regulated under U.S. medical device laws and are intended for distribution within the United States.
Catalogue
K-Y Personal Lubricant Ref K955648
Regimes: 510(k) Registry: 510(k)Lubricant, Otrho Personal Ref K790087
Regimes: 510(k) Registry: 510(k)Pulsatile Pump For Gonadorelin Acetate Ref K893488
Regimes: 510(k) Registry: 510(k)Advance(R) Pregnancy Test Ref K914990
Regimes: 510(k) Registry: 510(k)Fact* Home Pregnancy Test Ref K810581
Regimes: 510(k) Registry: 510(k)Nickerson's Med. Selective Culture Mediu Ref K800754
Regimes: 510(k) Registry: 510(k)Microscrape Ref K881151
Regimes: 510(k) Registry: 510(k)Conceptrol/Thin Prophylactics Ref K792634
Regimes: 510(k) Registry: 510(k)Advance Pregnancy Test Modification Ref K934516
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ortho Pharmaceutical Corp. have in the registry?
The registry currently lists 9 devices for Ortho Pharmaceutical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho Pharmaceutical Corp.'s devices?
Among its 9 most recently registered devices, Ortho Pharmaceutical Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Ortho Pharmaceutical Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Ortho Pharmaceutical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortho Pharmaceutical Corp. in the registry?
The most recently registered devices listed for Ortho Pharmaceutical Corp. include K-Y PERSONAL LUBRICANT, LUBRICANT, OTRHO PERSONAL, PULSATILE PUMP FOR GONADORELIN ACETATE and ADVANCE(R) PREGNANCY TEST.