25 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Sling - Amputee clip sling - “hook & loop" fastener
Device
EU MDR
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Eu Md Class 1
·ArjoHuntleigh AB·On the market·26 countries
ENTERPRISE 5000X
Device
EU MDR
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Eu Md Class 1
·ArjoHuntleigh AB·On the market·1 country
CROSS DONNING AID
Device
EU MDR
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Eu Md Class 1
·Camp Scandinavia AB·On the market
First Aid Eye Wash
Device
EU MDR
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Eu Md Class 2a
·Aurena Laboratories AB·On the market·4 countries
First Aid Eye Wash
Device
EU MDR
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Eu Md Class 2a
·Aurena Laboratories AB·On the market·4 countries
First Aid Eye Wash
Device
EU MDR
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Eu Md Class 2a
·Aurena Laboratories AB·On the market·2 countries
GIA Premix First Aid Eye Wash
Device
EU MDR
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Eu Md Class 2a
·Aurena Laboratories AB·Not intended for eu market
OBC BONE ANCHORED HEARING AID SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER
Device
EU MDR
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Eu Md Class 1
·Legrand AB·On the market
ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER
Device
EU MDR
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Eu Md Class 1
·Legrand AB·On the market
ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER
Device
EU MDR
·
Eu Md Class 1
·Legrand AB·On the market
ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER
Device
EU MDR
·
Eu Md Class 1
·Legrand AB·On the market
G1 002633 0004
Certificate
MDD Annex II (excluding section 4)·C-RAD Positioning AB·TÜV SÜD Product Service GmbH·4 Basic UDI-DIs
CROSS DONNING AID
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Camp Scandinavia AB·1 device
Safly AB
Importer
🇸🇪 Sweden·3 Manufacturers
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
FDA Enforcement
Class II
·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021
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
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
FDA Enforcement
Class II
·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
FDA Enforcement
Class II
·Terminated·Euro Diagnostica AB·January 10, 2018
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
FDA Enforcement
Class II
·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021