FDA Registration
Active
🇺🇸 United States
ARMM, INC.
Reg #: 2028523
·
FEI: 1000125147
·
Expires 2026
Products
40
Proprietary Names
27
Establishment Types
5
Classifications
40
Registration Details
- Registration Name
- ARMM, INC.
- Registration Number
- 2028523
- FEI Number
- 1000125147
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17744 SAMPSON LN.
- City
- HUNTINGTON BEACH
- State
- CA
- ZIP
- 92647
- Country
- US
Regulatory Submissions
- 510(k) Number
- K981286
Owner / Operator
- Firm Name
- ARMM, INC.
- Operator Number
- 9005125
- Address
- 17744 SAMPSON LN., --
- City
- Huntington Beach
- State
- CA
- Postal Code
- 92647
- Country
- US
- Correspondent
- ROGER - WOOD
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraoperative Surgical Angle Measurement Tool | QWL | Class 2 | Orthopedic | No | 2024-03-11 |
| File, Periodontic | EMR | Class 1 | Dental | No | 2009-10-05 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2013-02-18 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2016-01-18 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | KDH | Class 2 | Gastroenterology, Urology | No | 2010-10-26 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2013-01-25 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2013-01-29 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2013-01-29 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2013-01-29 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2013-01-29 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2013-01-31 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-01-25 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 1992-06-25 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2013-01-30 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2013-02-18 |
| Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS | Class 2 | Cardiovascular | No | 2013-01-30 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-03-22 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2013-01-30 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-01-30 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2016-01-18 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2007-12-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-12-21 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2013-02-18 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2013-01-31 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2013-01-25 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2013-03-22 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2013-02-18 |
| Instrument, Vitreous Aspiration And Cutting, Battery-Powered | HKP | Class 2 | Ophthalmic | No | 2013-01-31 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2013-02-05 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2013-01-30 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2013-03-22 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-25 |
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2016-01-18 |
| Catheter, Pediatric, General & Plastic Surgery | GBN | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2013-01-25 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2008-10-06 |
Proprietary Names
Ruthless Spine RJB
Subantral Membrane Elevators
Conformer
Q System
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
Wire
Titanium Hip Tool
Bone Tool
OT-A System
Titanium TSY Shoulder Plate
SuperFlow
EndoSI Suction Irrigator
Tip Protector
Fluted Burrs
Tubing
HVP Tubing
Y' Small Bore Infiltration Tubing
Standard Ultra-Limp Tubing
CB Infiltration Tubing
MB Ulta-Limp Tubing
Large Bore Infiltration Tubing
Pathway Introducer
Hemorrhage Occluder Pin With Applicator
MEDDRAINS
TS Bone Hip Tool
SuperFlow Tubing
Titanium Hip Tool Locking Plate
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device
Repack or Relabel Medical Device
Remanufacture Medical Device