Data / Medical devices / United States / Armm, Inc.
Armm, Inc.: FDA-registered device maker in Huntington Beach, CA, United States, 4 510(k) clearances
Armm, Inc. is registered with the FDA (registration 2028523) in Huntington Beach, CA, United States. It lists 40 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 19, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2028523
- FEI number
- 1000125147
- Address
- 17744 Sampson LN., Huntington Beach, CA, United States, 92647
- Owner or operator
- ARMM, INC. (9005125)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- June 25, 1992
- Registered through
- 2026
- Brand names listed
- Bone Tool, CB Infiltration Tubing, Conformer, EndoSI Suction Irrigator, Fluted Burrs, HVP Tubing, Hemorrhage Occluder Pin With Applicator, Large Bore Infiltration Tubing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Arthroscopic | NBH | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Accessories, Catheter | KGZ | 1 | Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Exhaust, Surgical | FYD | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Barrier, Animal Source, Intraoral | NPL | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Cardiac Ablation Percutaneous Catheter | LPB | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | KDH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Catheter, Pediatric, General & Plastic Surgery | GBN | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Conformer, Ophthalmic | HQN | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| File, Periodontic | EMR | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Implant, Eye Sphere | HPZ | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | 2 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Vitreous Aspiration And Cutting, Battery-Powered | HKP | 2 | Contract manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Contract manufacturer, Contract sterilizer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Intraoperative Surgical Angle Measurement Tool | QWL | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Stabilizer, Heart | MWS | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Trephine | HWK | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Contract manufacturer, Contract sterilizer | 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 |
|---|
| June 19, 1998 | K981286 | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | KDH | Substantially Equivalent | Armm, Inc. | accessdata.fda.gov |
| September 23, 1993 | K923201 | ENDOSI SUCTION IRRIGATOR | GCJ | Substantially Equivalent | Armm, Inc. | accessdata.fda.gov |
| September 3, 1993 | K922245 | SUPER-FLOW TUBING | HIF | Substantially Equivalent | Armm, Inc. | accessdata.fda.gov |
| August 6, 1993 | K931607 | MEDDRAINS | GBN | Substantially Equivalent | Armm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Irrigation, Ocular Surgery
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Accessories, Arthroscopic
- All makers of Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- All makers of Plate, Fixation, Bone
- All makers of Accessories, Catheter
Updated June 19, 1998. 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.