25 results · 28ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Sling - Amputee clip sling - “hook & loop" fastener

Device
EU MDR · Eu Md Class 1 ·ArjoHuntleigh AB·On the market·26 countries

ENTERPRISE 5000X

Device
EU MDR · Eu Md Class 1 ·ArjoHuntleigh AB·On the market·1 country

CROSS DONNING AID

Device
EU MDR · Eu Md Class 1 ·Camp Scandinavia AB·On the market

First Aid Eye Wash

Device
EU MDR · Eu Md Class 2a ·Aurena Laboratories AB·On the market·4 countries

First Aid Eye Wash

Device
EU MDR · Eu Md Class 2a ·Aurena Laboratories AB·On the market·4 countries

First Aid Eye Wash

Device
EU MDR · Eu Md Class 2a ·Aurena Laboratories AB·On the market·2 countries

GIA Premix First Aid Eye Wash

Device
EU MDR · 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 · 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

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 · 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