Data / Medical devices / United States / NOAH MEDICAL Corp.
NOAH MEDICAL Corp.: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
NOAH MEDICAL Corp. is registered with the FDA (registration 3021325287) in San Jose, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2023. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021325287
- Address
- 2075 Zanker Rd, San Jose, CA, United States, 95131
- Owner or operator
- Noah Medical (10087546)
- Roles
- Manufacturer
- First device listed
- March 13, 2023
- Registered through
- 2026
- Brand names listed
- Galaxy System, Galaxy system bronchoscope and accessory kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 1, 2023 | K223144 | Galaxy System | EOQ | Substantially Equivalent | Noah Medical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 12, 2025 | 97656 | Class II | Ongoing | Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patien | Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. | accessdata.fda.gov |
| October 28, 2024 | 95585 | Class II | Ongoing | Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. | Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn inc | accessdata.fda.gov |
| October 25, 2024 | 95712 | Class II | Ongoing | Galaxy System (GAL-001) | Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which cou | accessdata.fda.gov |
| October 25, 2024 | 95574 | Class II | Ongoing | Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001) | Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope be | accessdata.fda.gov |
| March 9, 2024 | 94193 | Class II | Ongoing | Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic | Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. | accessdata.fda.gov |
Compare with other makers
Updated November 26, 2025. 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.