SPEEDWAY

FDA Device Registration & Listing · India Delhi, IN · Registration 3006550126

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006550126
FEI Number
3006550126
Entity Name
SPEEDWAY
City/State/Country
India Delhi, IN
Establishment Address
A-67/5 G.T Karnal Road Industrial Area, Delhi, India Delhi 110033, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Speedway Surgical Co. (Owner Number: 10028319)
Owner / Operator Contact Address
A-67/5 GT Karnal Road Industrial Area, Delhi, India, IN-DL 110033, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Indirect Ophthalmoscope wireless trocar system Ophthalmic retractors Lacrimal Probes, lacrimal intubation set depressor tonometer Eye scissors, westcott, corneal, vannas, stevens, iris, knapp, others Trial Lens Ophthalmic chair Eye conformer instrument table motorised Ophthalmic curette, chalzion curette eye elevator color vision test Artificial eyes Prism bar surgical cap Ophthalmic spatulas Diathermy machine plastic tray, steel tray , sterilization tray Corneal trephine Ophthalmic rings eye drape, patient drape Ophthalmic chair manual ophthalmic clamps Instrument Table, stand Diagnostic lenses Kelly's punch, corneal punch Ophthalmic Forceps, suture tying, corneal, others Curette Hooks, Choppers, Picks, Manipulators diagnostic strips spud Indirect Ophthalmoscope wireless Needle Holder, Ophthalmic needles cannula irrigation/aspiration, IA handpiece trocar cannula cannula irrigation/aspiration surgical gown, examination gown Slit Lamp medical disinfectant eye markers Expressor, Meibomian Expressor Opthalmic gauge depressor Eye Loupe Trial Lens set Lacrimal dilator, castroveijo dilator Alger Brush instrument table manual ophthalmic cannula shoe cover Markers and calipers exophthalmometer trocar

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MSG Ophthalmoscopes, Replacement Batteries, Hand-Held Ophthalmic Class 2 886.1570 2024-07-15
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-20
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2013-08-08
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2013-04-10
HKY Tonometer, Manual Ophthalmic Class 2 886.1930 2019-04-18
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HPB Clip, Lens, Trial, Ophthalmic Ophthalmic Class 1 886.1410 2009-01-20
HME Chair, Ophthalmic, Ac-Powered Ophthalmic Class 1 886.1140 2009-01-20
HQN Conformer, Ophthalmic Ophthalmic Class 2 886.3130 2009-01-20
HRJ Table, Instrument, Powered, Ophthalmic Ophthalmic Class 1 886.4855 2009-01-21
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HTE Elevator General, Plastic Surgery Class 1 878.4800 2021-02-23
HIT Tester, Color Vision Ophthalmic Class 1 886.1170 2021-03-27
QWU Prosthesis, Eyelid Spacer/Graft, Polymer Ophthalmic Class 2 886.3130 2024-07-15
HKW Prism, Bar, Ophthalmic Ophthalmic Class 1 886.1650 2009-01-20
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2023-01-06
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HPY Unit, Electrolysis, Battery-Powered, Ophthalmic Ophthalmic Class 1 886.4250 2009-01-20
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-10-09
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2009-01-20
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2021-12-30
HMD Chair, Ophthalmic, Manual Ophthalmic Class 1 886.1140 2009-01-20
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
NOI Stand, Instrument, Ophthalmic, Battery Powered Ophthalmic Class 1 886.1860 2024-07-15
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2018-10-05
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2013-04-10
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
KYD Strip, Schirmer Ophthalmic Class 1 886.1800 2018-10-05
HNA Spud, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2018-10-05
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2009-01-21
MXY Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal Ophthalmic Class 1 886.4350 2009-01-21
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2009-01-21
FME Gown, Examination General Hospital Class 1 880.6265 2023-01-05
PUE Biomicroscope, Slit-Lamp, Ac-Powered, Exempt Ophthalmic Class 2 886.1850 2024-07-15
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2021-01-04
HMR Marker, Ocular Ophthalmic Class 1 886.4570 2019-04-04
HNS Expressor Ophthalmic Class 1 886.4350 2024-07-15
HLN Gauge, Lens, Ophthalmic Ophthalmic Class 1 886.1420 2009-01-20
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2013-04-10
HJH Loupe, Binocular, Low Power Ophthalmic Class 1 886.5120 2024-07-15
HPC Set, Lens, Trial, Ophthalmic Ophthalmic Class 1 886.1405 2009-01-20
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2013-08-08
OHW Burr, Corneal, Battery Powered, Rust Ring Removal Ophthalmic Class 1 886.4070 2024-07-15
HRK Table, Instrument, Manual, Ophthalmic Ophthalmic Class 1 886.4855 2009-01-21
MXY Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal Ophthalmic Class 1 886.4350 2009-01-21
BWP Shoe And Shoe Cover, Conductive General, Plastic Surgery Class 1 878.4040 2023-01-06
HLF Device, Measuring, Lens Radius, Ophthalmic Ophthalmic Class 1 886.1430 2009-01-20
HLS Exophthalmometer Ophthalmic Class 1 886.1270 2021-03-27
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2021-07-07

Official Correspondent

Jatin Pahwa

US Agent Details

Palvinder Chahal Email: td@speedwaydelhi.com Phone: (832) 9193784

Related Public Records

Same Entity

Speedway Surgical Co.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K871646 Ocular Instruments, Inc. TANNE CORNEAL CUTTING BLOCK 1987-05-18
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30
K900478 Woodlyn, Inc. WOODLYN FULL APERTURE TRIAL LENS SET 1990-02-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0308-2026 Alcon Research LLC 1
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0039-2026 CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel 2
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
Z-0040-2026 CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel 2
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0011-2019 Ellex iScience, Inc. 1
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006550126. Last updated year: 2026. Please use registration number 3006550126 when referencing this establishment in official correspondence.
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