510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NOAH MEDICAL Corp.

San Jose, CA, US

NOAH MEDICAL Corp. appears in FDA device records in San Jose, CA. FDA records list one 510(k) clearance, no PMA records and 3 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
5
Registered establishments
3

510(k) clearance history

FDA records hold 1 510(k) clearance for NOAH MEDICAL Corp. in 2023.

Clearances by year, as a table
510(k) clearance decisions for NOAH MEDICAL Corp., by decision year
YearClearances
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223144Galaxy SystemEOQSubstantially Equivalent

Registered establishments

FDA registered establishments for NOAH MEDICAL Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30213252873021325287NOAH MEDICAL Corp.2075 Zanker Rd, San Jose, CA 95131 US2026
30272057233027205723NOAH MEDICAL Corp.1391 Geneva Dr, Sunnyvale, CA 94089 US2026
30336284773033628477NOAH MEDICAL Corp.975 Industrial Rd, San Carlos, CA 94070 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0598-2026Brand 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 patient airways for diagnostic and therapeutic procedure.Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.Class IIOpen, Classified
Z-0742-2025Galaxy 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 including the possibility of pneumothorax.Class IIOpen, Classified
Z-0693-2025Galaxy 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 could lead to lung injury/pneumothorax.Class IIOpen, Classified
Z-0679-2025Galaxy 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 bending section significantly articulated.Class IIOpen, Classified
Z-1734-2024Galaxy 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 procedures.Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain