18 results
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15ms
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Sources: EU EUDAMED, US FDA
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 patient airways for diagnostic and therapeutic procedure.
FDA Enforcement
Class II
·Ongoing·Noah Medical Corporation·December 3, 2025
Galaxy System (GAL-001)
FDA Enforcement
Class II
·Ongoing·Noah Medical·December 25, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
FDA Enforcement
Class II
·Ongoing·Noah Medical·December 18, 2024
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
FDA Enforcement
Class II
·Ongoing·Noah Medical·January 1, 2025
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
FDA Enforcement
Class II
·Ongoing·Ethicon, Inc.·May 18, 2022
Temporary Titanium Abutments
FDA Enforcement
Class II
·Ongoing·DDS Lab·February 12, 2025
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
BD Kiestra" ReadA; Catalog No.: 446948.
FDA Enforcement
Class II
·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014