Data / Medical devices / United States / Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)
Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International): FDA-registered device maker in Bridgewater, NJ, United States, 3 510(k) clearances
Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International) is registered with the FDA (registration 3009443653) in Bridgewater, NJ, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 18, 2017. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009443653
- Address
- 400 Somerset Corp Blvd. Suite 1, Bridgewater, NJ, United States, 08807
- Owner or operator
- Bausch Health US LLC (10039156)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 17, 2014
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Barrier, Animal Source, Intraoral | NPL | 2 | Complaint file establishment | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2017 | K163714 | OSSIX BONE | NPM | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| August 4, 2016 | K160281 | OSSIX PLUS | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| August 4, 2016 | K153549 | OSSIX VOLUMAX | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 13, 2017 | 77289 | Class II | Terminated | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air | SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated method, NB-TM-261, In November 2016. The particle size specification set in NB-SPEC-039 for Dv10, Dv50, & Dv90 are a mean value of no more than 3.0m, 5.5 m, and 15m respectively. Initial testing of the nebulizers yielded four units that delivered par | accessdata.fda.gov |
| January 29, 2016 | 73678 | Class II | Terminated | Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a sec | It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period. | accessdata.fda.gov |
| September 21, 2015 | 72630 | Class II | Terminated | Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol. | The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Barrier, Animal Source, Intraoral
- All makers of Bone Grafting Material, Animal Source
Updated July 18, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.