Data / Medical devices / India / Speedway
Speedway: FDA-registered device maker in India Delhi, India, 1 510(k) clearance
Speedway is registered with the FDA (registration 3006550126) in India Delhi, India. It lists 69 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 8, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006550126
- Address
- A-67/5 G.T Karnal Road Industrial Area Delhi, India Delhi, India, 110033
- Owner or operator
- Speedway Surgical Co. (10028319)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 20, 2009
- Registered through
- 2026
- Brand names listed
- Alger Brush, Artificial eyes, Bipolar Cable, Braunstein caliper, castroveijo caliper, Corneal trephine, Curette, Diagnostic lenses, Diathermy machine and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | PUE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cable | ISN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Trocar, Ophthalmic | NGY | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Ophthalmic, Ac-Powered | HME | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Ophthalmic, Manual | HMD | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Eyelid, Ophthalmic | HOD | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Muscle, Ophthalmic | HOB | 1 | Manufacturer | accessdata.fda.gov |
| Clip, Lens, Trial, Ophthalmic | HPB | 1 | Manufacturer | accessdata.fda.gov |
| Conformer, Ophthalmic | HQN | 2 | Manufacturer | accessdata.fda.gov |
| Cover, Cast | KIA | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Ophthalmic | HNZ | 1 | Manufacturer | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Manufacturer | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Manufacturer | accessdata.fda.gov |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Patient, Ophthalmic | HMT | 2 | Manufacturer | accessdata.fda.gov |
| Elevator | HTE | 1 | Manufacturer | accessdata.fda.gov |
| Exophthalmometer | HLS | 1 | Manufacturer | accessdata.fda.gov |
| Expressor | HNS | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Manufacturer | accessdata.fda.gov |
| Frame, Trial, Ophthalmic | HPA | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Lens, Ophthalmic | HLN | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Condensing, Diagnostic | HJL | 1 | Manufacturer | accessdata.fda.gov |
| Loupe, Binocular, Low Power | HJH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Manufacturer | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Manufacturer | accessdata.fda.gov |
| Mirror, Headband, Ophthalmic | HKF | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Manufacturer | accessdata.fda.gov |
| Ophthalmoscope, Battery-Powered | HLJ | 2 | Manufacturer | accessdata.fda.gov |
| Ophthalmoscopes, Replacement Batteries, Hand-Held | MSG | 2 | Manufacturer | accessdata.fda.gov |
| Prism, Bar, Ophthalmic | HKW | 1 | Manufacturer | accessdata.fda.gov |
| Prism, Fresnel, Ophthalmic | HKT | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Eyelid Spacer/Graft, Polymer | QWU | 2 | Manufacturer | accessdata.fda.gov |
| Punch, Corneo-Scleral | HNJ | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Manufacturer | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Manufacturer | accessdata.fda.gov |
| Set, Lens, Trial, Ophthalmic | HPC | 1 | Manufacturer | accessdata.fda.gov |
| Shell, Scleral | HQT | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Manufacturer | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Manufacturer | accessdata.fda.gov |
| Spectacle, Operating (Loupe), Ophthalmic | HOH | 1 | Manufacturer | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Manufacturer | accessdata.fda.gov |
| Spoon, Ophthalmic | HNB | 1 | Manufacturer | accessdata.fda.gov |
| Spud, Ophthalmic | HNA | 1 | Manufacturer | accessdata.fda.gov |
| Stand, Instrument, Ophthalmic, Battery Powered | NOI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Strip, Schirmer | KYD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Manufacturer | accessdata.fda.gov |
| Table, Instrument, Manual, Ophthalmic | HRK | 1 | Manufacturer | accessdata.fda.gov |
| Table, Instrument, Powered, Ophthalmic | HRJ | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tester, Color Vision | HIT | 1 | Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Manufacturer | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Electrolysis, Battery-Powered, Ophthalmic | HPY | 1 | Manufacturer, Repackager or relabeler | 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 |
|---|
| May 8, 1995 | K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE | HKY | Substantially Equivalent | Rudolf Riester GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Cast
- All makers of Tray, Surgical, Instrument
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Chair, Ophthalmic, Manual
- All makers of Gauge, Lens, Ophthalmic
- All makers of Unit, Electrolysis, Battery-Powered, Ophthalmic
Updated May 8, 1995. 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.