17 results
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12ms
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Sources: EU EUDAMED, US FDA
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
FDA Recall
Open, Classified
·North Coast Medical Inc·Product code ILH·August 18, 2023
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.
FDA Recall
Open, Classified
·LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente·Product code QBD·June 3, 2020
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
FDA Recall
Open, Classified
·Product code OGR·February 25, 2026
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
FDA Recall
Open, Classified
·Brasseler USA I Lp·Product code EJL·January 11, 2024
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Recall
Open, Classified
·Dentsply IH, Inc.·Product code NDP·July 24, 2025
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Recall
Open, Classified
·Dentsply IH, Inc.·Product code NDP·July 24, 2025
NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
FDA Recall
Open, Classified
·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
FDA Recall
Open, Classified
·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No
FDA Recall
Open, Classified
·THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom·Product code ILY·July 24, 2025
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A
FDA Recall
Open, Classified
·THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom·Product code ILY·July 24, 2025
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A
FDA Recall
Open, Classified
·THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom·Product code ILY·July 24, 2025
G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
FDA Recall
Open, Classified
·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022
Mito Red Light, Super Mobile
FDA Recall
Open, Classified
·MITO RED LIGHT INC·Product code ILY·February 12, 2025
Diowave Laser System, REF: Diowave 250W
FDA Recall
Open, Classified
·Technological Medical Advancements LLC·Product code ILY·January 9, 2026
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
FDA Recall
Open, Classified
·THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom·Product code ILY·November 20, 2023
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
FDA Recall
Open, Classified
·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No
FDA Recall
Open, Classified
·THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom·Product code ILY·July 24, 2025