316 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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ASPIRE GROUP NA LTD
FDA registration
ASPIRE GROUP NA LTD·2 products·🇨🇦 Canada
SAMPLE TRANSPORT FOR NA TESTING
Device
EU IVDR
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Eu Ivd Class A
·Norgen Biotek Corporation·On the market
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
FDA Enforcement
Class II
·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·June 18, 2025
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.
FDA Enforcement
Class II
·Ongoing·Raz Design Inc·March 18, 2026
Dominion Biologicals Limited
Manufacturer
🇨🇦 Canada·TÜV Rheinland LGA Products GmbH
Mespere LifeSciences Inc
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·2 Importers·SGS Belgium NV
Batrik Medical Manufacturing Inc.
Manufacturer
🇨🇦 Canada·131 Basic UDI-DIs·1075 Devices·5 Importers·SGS Belgium NV
NuMED Canada, Inc.
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·9 Importers·SGS Belgium NV
Circle Cardiovascular Imaging Inc
Manufacturer
🇨🇦 Canada·6 Basic UDI-DIs·7 Devices·3 Importers·BSI Group The Netherlands B.V., SGS Belgium NV, and BSI Group The Netherlands B.V.
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Enforcement
Class III
·Terminated·DNA Genotek Inc.·September 30, 2020
ORAcollect RNA: ORE-100
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·9 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·9 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·9 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·10 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·10 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·10 countries
StrokeSENS
Device
EU MDD
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Eu Md Class 2a
·Circle Cardiovascular Imaging Inc·On the market·8 countries
SKIN MARKING DERMOGRAPHIC PENCILS AND PENS
Device
EU MDD
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Eu Md Class 1
·Batrik Medical Manufacturing Inc.·On the market·4 countries