FDA Registration
Active
🇺🇸 United States
MAHE MEDICAL USA
Reg #: 3013011598
·
FEI: 3013011598
·
Expires 2026
Products
76
Proprietary Names
2
Establishment Types
2
Classifications
76
Registration Details
- Registration Name
- MAHE MEDICAL USA
- Registration Number
- 3013011598
- FEI Number
- 3013011598
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3821 Beech Street
- City
- Laramie
- State
- WY
- ZIP
- 82070
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110655
Owner / Operator
- Firm Name
- Mahe Medical USA
- Operator Number
- 10052835
- Address
- 3821 Beech Street
- City
- Laramie
- State
- WY
- Postal Code
- 82070
- Country
- US
- Correspondent
- Keith Hamilton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2025-01-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-01-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-20 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2025-01-20 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2025-01-20 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2025-01-20 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-01-20 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2025-01-20 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Bender | HXW | Class 1 | Orthopedic | No | 2025-01-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2025-01-20 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2025-01-20 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2025-01-20 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2025-01-20 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2025-01-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-01-20 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2025-01-20 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-01-20 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-01-20 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-01-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-01-20 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2025-01-20 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2025-01-20 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2025-01-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-01-20 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2025-01-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-01-20 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2025-01-20 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2025-01-20 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2025-04-16 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2025-01-20 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2025-01-20 |
| Template | HWT | Class 1 | Orthopedic | No | 2025-01-20 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-12-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2025-01-20 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Electrosurgical Device | DWG | Class 2 | General, Plastic Surgery | No | 2025-01-20 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2025-01-20 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2025-01-20 |
| Camera, Television, Endoscopic, With Audio | FWG | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2025-01-20 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-01-20 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-01-20 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2025-01-20 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2025-01-20 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2025-01-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-01-20 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2025-01-20 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2025-01-20 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2025-01-20 |
Proprietary Names
MAHE
Cartilage Punch - Mahe
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198