Contract manufacturerR.K. Manufacturing (Danbury, CT)ConnecticutGeneral hospitalGeneral and plastic surgeryGastroenterology and urologyObstetrics and gynecologyOrthopedicRadiologyClass IIClass I
R.K. Manufacturing
Contract manufacturer · Danbury, CT
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1226146 (openFDA record; or search FDA's registration database)
- FEI number
- 3002680121
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- R.K. MFG. CORP. OF CONNECTICUT (FDA owner/operator no. 10024924)
- Registered address
- 34 Executive Drive, Danbury, CT 06810
- Contract listings
- 32 device listings, 24 product codes, first listed Oct 7, 2010
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Jan 27, 2025 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract manufacturing | Oct 26, 2022 |
| GAB | Needle, Suturing, Disposable | Class I | General and plastic surgery | Contract manufacturing | Apr 16, 2026 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | Class II | General and plastic surgery | Contract manufacturing | Feb 27, 2018 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract manufacturing | Oct 7, 2010 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Mar 24, 2014 |
| HEB | Tampon, Menstrual, Unscented | Class II | Obstetrics and gynecology | Contract manufacturing | Jan 14, 2019 |
| HHW | Pessary, Vaginal | Class II | Obstetrics and gynecology | Contract manufacturing | Jun 10, 2024 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jan 5, 2021 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 11, 2025 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Mar 16, 2021 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Class II | Orthopedic | Contract manufacturing | Oct 26, 2022 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 28, 2025 |
| LZB | Finger Cot | Class I | General hospital | Contract manufacturing | Feb 11, 2022 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Mar 11, 2025 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Oct 6, 2023 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Mar 28, 2022 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Oct 20, 2020 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Jan 9, 2014 |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | Gastroenterology and urology | Contract manufacturing | Mar 24, 2014 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | Class II | General and plastic surgery | Contract manufacturing | Mar 24, 2014 |
| OCW | Endoscopic Tissue Approximation Device | Class II | Gastroenterology and urology | Contract manufacturing | Aug 31, 2026 |
| OVB | Hydrogel Spacer | Class II | Radiology | Contract manufacturing | Feb 10, 2023 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract manufacturing | Oct 26, 2022 |