19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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CARBON DIOXIDE (MEDICAL DEVICE) 2.5L
Device
EU MDD
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Eu Md Class 2a
·Linde Sverige AB (Linde Gas)·On the market·8 countries
CARBON DIOXIDE (MEDICAL DEVICE) 2.5L
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Linde Sverige AB (Linde Gas)·1 device
DD 2349717-1
Certificate
MDD Annex V·Linde Sverige AB (Linde Gas)·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
Linde Sverige AB (Linde Gas)
Importer
🇸🇪 Sweden
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
FDA Enforcement
Class II
·Terminated·Etac Supply Center Ab·July 25, 2012
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
FDA Enforcement
Class II
·Terminated·Breas Medical AB·July 22, 2015
Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
FDA Enforcement
Class II
·Terminated·Etac Supply Center Ab·August 19, 2015
Medilens Nordic AB
Importer
🇸🇪 Sweden·29 Manufacturers