Contract manufacturerB & G MFG. CO. (Hatfield, PA)PennsylvaniaCardiovascularGastroenterology and urologyNeurologyOrthopedicClass IIClass IClass IIIUnclassified
B & G MFG. CO.
Contract manufacturer · Hatfield, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3004188066 (openFDA record; or search FDA's registration database)
- FEI number
- 3004188066
- Registered for
- FDA registration year 2027
- Establishment types
- Contract manufacturer
- Owner or operator
- B&G Manufacturing Company (FDA owner/operator no. 9058527)
- Registered address
- 3067 UNIONVILLE PIKE, Hatfield, PA 19440
- Contract listings
- 88 device listings, 37 product codes, first listed Apr 15, 2013
- 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 |
|---|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Class II | Cardiovascular | Contract manufacturing | Jan 5, 2022 |
| FIP | Subsystem, Water Purification | Class II | Gastroenterology and urology | Contract manufacturing | Jan 5, 2022 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Mar 27, 2023 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 23, 2020 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Mar 27, 2023 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 23, 2020 |
| JDO | Device, Fixation, Proximal Femoral, Implant | Class II | Orthopedic | Contract manufacturing | Jan 14, 2026 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Mar 21, 2016 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 27, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Apr 7, 2017 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 14, 2026 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract manufacturing | Mar 27, 2023 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Jan 5, 2022 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Mar 30, 2016 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 28, 2016 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 27, 2023 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Mar 27, 2023 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Apr 15, 2013 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 29, 2016 |
| PGM | Growing Rod System | Class II | Orthopedic | Contract manufacturing | Mar 27, 2023 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract manufacturing | Dec 12, 2019 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract manufacturing | Jan 5, 2022 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | Class II | Orthopedic | Contract manufacturing | Jul 30, 2026 |