Data / Medical devices / United States / Roechling Medical Lancaster, LLC
Roechling Medical Lancaster, LLC: FDA-registered device maker in Denver, PA, United States, 2 510(k) clearances
Roechling Medical Lancaster, LLC is registered with the FDA (registration 2531321) in Denver, PA, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 7, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2531321
- FEI number
- 3001237758
- Address
- 44 Denver RD., Denver, PA, United States, 17517
- Owner or operator
- Roechling Medical Rochester, L.P. (10048821)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 10, 2018
- Registered through
- 2026
- Brand names listed
- ARTHROSCOPE, BioSphere MIS Putty, BioSphere Putty Bioactive Bone Graft, CANNULA, TROCAR, OPHTHALMIC, CATHETER, CONTINUOUS FLUSH, Durastat, FILLER, BONE VOID, CALCIUM COMPOUND, Platelet And Plasma Separator For Bone Graft Handling and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Allergen And Vaccine Delivery Needles | SCL | 2 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Cannula, Trocar, Ophthalmic | NGY | 1 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Contract manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Contract manufacturer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Contract manufacturer | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| August 7, 2003 | K031630 | BIFURCATED ALLERGY SKIN TESTING NEEDLE | SCL | Substantially Equivalent | Precision Medical Products, Inc. | accessdata.fda.gov |
| September 19, 2001 | K012515 | BIFURCATED VACCINATING NEEDLE | SCL | Substantially Equivalent | Precision Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Arthroscope
- All makers of Allergen And Vaccine Delivery Needles
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Cannula, Trocar, Ophthalmic
- All makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Updated August 7, 2003. 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.