Data / Medical devices / United States / BihlerMed, LLC
BihlerMed, LLC: FDA-registered device maker in Phillipsburg, NJ, United States, 2 510(k) clearances
BihlerMed, LLC is registered with the FDA (registration 3005977121) in Phillipsburg, NJ, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005977121
- Address
- 85 Industrial Drive, Phillipsburg, NJ, United States, 08865
- Owner or operator
- BihlerMed, LLC (9092868)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 17, 2007
- Registered through
- 2026
- Brand names listed
- Chemo Mouthpiece, Plexitome, SCINTILLANT LIGHT, SafeBreak Vascular, Scintillant Dual Tip Surgical Light, Scintillant Retractor, Scintillant Suction, Scintillant Surgical Light
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter And Tip, Suction | JOL | 2 | Manufacturer | accessdata.fda.gov |
| Cystotome | HNY | 1 | Manufacturer | accessdata.fda.gov |
| Intraoral Cooling Device | QUA | 2 | Contract manufacturer | accessdata.fda.gov |
| Intravenous Catheter Force-Activated Separation Device. | QOI | 2 | Contract manufacturer | accessdata.fda.gov |
| Lamp, Surgical | FTD | 2 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 5, 2013 | K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT | FTD | Substantially Equivalent | Engineered Medical Solutions Co., LLC | accessdata.fda.gov |
| June 20, 2007 | K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | FTD | Substantially Equivalent | Engineered Medical Solutions Co., LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter And Tip, Suction
- All makers of Lamp, Surgical
- All makers of Intravenous Catheter Force-Activated Separation Device.
- All makers of Cystotome
- All makers of Intraoral Cooling Device
- All makers of Retractor
Updated December 5, 2013. 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.