Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2028523

FEI Number

1000125147

Entity Name

ARMM, INC.

City/State/Country

HUNTINGTON BEACH, CA, US

Establishment Address

17744 SAMPSON LN., HUNTINGTON BEACH, CA 92647, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

ARMM, INC. (Owner Number: 9005125)

Owner / Operator Contact Address

17744 SAMPSON LN., --, Huntington Beach, CA 92647, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ruthless Spine RJB Subantral Membrane Elevators Conformer Q System SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS Wire Q System Titanium Hip Tool Bone Tool OT-A System Bone Tool Titanium Hip Tool Titanium TSY Shoulder Plate SuperFlow EndoSI Suction Irrigator Tip Protector Fluted Burrs Tubing Wire 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 Titanium TSY Shoulder Plate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWL	Intraoperative Surgical Angle Measurement Tool	Orthopedic	Class 2	888.4560	2024-03-11
EMR	File, Periodontic	Dental	Class 1	872.4565	2009-10-05
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2013-02-18
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2016-01-18
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-25
KDH	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration	Gastroenterology, Urology	Class 2	876.5980	2010-10-26
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-25
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2013-01-25
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2013-01-29
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-01-29
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2013-01-29
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2013-01-29
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2013-01-31
HWK	Trephine	Orthopedic	Class 1	888.4540	2013-01-25
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	1992-06-25
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2013-01-30
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2013-02-18
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4420	2013-01-30
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-03-22
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2013-01-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-30
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2016-01-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-12-21
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2013-01-25
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2013-02-18
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-01-28
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2013-01-31
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2013-01-25
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2013-03-22
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2013-01-28
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2013-02-18
HKP	Instrument, Vitreous Aspiration And Cutting, Battery-Powered	Ophthalmic	Class 2	886.4150	2013-01-31
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2013-01-31
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-02-05
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-01-30
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2013-03-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-25

Official Correspondent

ROGER WOOD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARMM, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
K120857	Ncontact Surgical, Inc.	EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX	2012-11-13
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028523. Last updated year: 2026. Please use registration number 2028523 when referencing this establishment in official correspondence.