Data / Medical devices / United States / Mahe Medical Usa
Mahe Medical Usa: FDA-registered device maker in Laramie, WY, United States, 17 510(k) clearances
Mahe Medical Usa is registered with the FDA (registration 3013011598) in Laramie, WY, United States. It lists 76 device types. The FDA files 17 510(k) clearances under its listings, the newest dated May 29, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013011598
- Address
- 3821 Beech Street, Laramie, WY, United States, 82070
- Owner or operator
- Mahe Medical USA (10052835)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 30, 2024
- Registered through
- 2026
- Brand names listed
- Cartilage Punch - Mahe, MAHE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Camera, Television, Endoscopic, With Audio | FWG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cerclage, Fixation | JDQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrode, Electrosurgical, Active, Urological | FAS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical Device | DWG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Resectoscope | FJL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Resectoscope, Working Element | FDC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Saw | HSO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Saw, Powered, And Accessories | HAB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Staple Driver | HXJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Specification developer | 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 29, 2012 | K120360 | ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS | HRS | Substantially Equivalent | Ortho Solutions Limited | accessdata.fda.gov |
| April 24, 2012 | K120645 | PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 7, 2012 | K111678 | ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS | HRS | Substantially Equivalent | Ortho Solutions Limited | accessdata.fda.gov |
| December 19, 2011 | K110895 | ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS | HWC | Substantially Equivalent | Ortho Solutions Limited | accessdata.fda.gov |
| October 27, 2011 | K110655 | MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Mahe Medical GmbH | accessdata.fda.gov |
| May 13, 2011 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Mahe Medical GmbH | accessdata.fda.gov |
| January 20, 2011 | K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | HWE | Substantially Equivalent | Ortho Solutions Limited | accessdata.fda.gov |
| April 28, 2006 | K060654 | DSI PINS AND WIRES | HTY | Substantially Equivalent | Delta Surgical Instruments, Inc. | accessdata.fda.gov |
| August 5, 1999 | K991426 | MAHE INSTRUMENTS | FDC | Substantially Equivalent | Mahe Intl., Inc. | accessdata.fda.gov |
| December 5, 1994 | K942823 | MAHE INSTRUMENTS | DWG | Substantially Equivalent | Mahe Intl., Inc. | accessdata.fda.gov |
| November 2, 1994 | K942821 | MAHE INSTRUMENTS | GEI | Substantially Equivalent | Mahe-Medizintechnik | accessdata.fda.gov |
| August 23, 1994 | K942819 | TROCAR WITH SHIELD | GCJ | Substantially Equivalent | Mahe-Medizintechnik | accessdata.fda.gov |
| June 27, 1994 | K933768 | COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES | HET | Substantially Equivalent | Mahe-Medizintechnik | accessdata.fda.gov |
| May 26, 1994 | K933767 | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | HFB | Substantially Equivalent | Mahe-Medizintechnik | accessdata.fda.gov |
| March 23, 1994 | K933770 | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE | LRC | Substantially Equivalent | Mahe-Medizintechnik | accessdata.fda.gov |
| March 14, 1994 | K935442 | MAHE INSTRUMENTS | GCJ | Substantially Equivalent | Mahe-Medizintechnik | accessdata.fda.gov |
| February 1, 1994 | K933772 | PUNCH SURGICAL | LXH | Substantially Equivalent | Mahe-Medizintechnik | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical
- All makers of Washer, Bolt Nut
- All makers of Plate, Fixation, Bone
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Screw, Fixation, Bone
- All makers of Wrench
Updated May 29, 2012. 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.