4,782 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIA-900
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code KHO·April 6, 2018
REMOVE DC CUTTER SET 12
FDA Adverse Event
Malfunction
·OVESCO ENDOSCOPY AG·Product code QAG·October 16, 2023
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
OMRON 10 SERIES UPPER ARM BLOOD PRESSURE MONITOR
FDA Adverse Event
Malfunction
·OMRON HEALTHCARE CO., LTD.·Product code DXN·April 1, 2021
CMC POSTERIOR SPINE PACK
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES, INC.·Product code LRO·March 20, 2023
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 Recall
Terminated
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020
Endoscopic Electrosurgical Clip Cutting System
FDA classification
FDA Class 2
·Endoscopic Electrosurgical Clip Cutting System
DEN TAG S.R.L.
FDA registration
DEN TAG S.R.L.·64 products·🇮🇹 Italy
MACO BAG CORP.
FDA registration
MACO BAG CORP.·2 products·🇺🇸 United States
S & T AG
FDA registration
S & T AG·10 products·🇨🇭 Switzerland
MAG & MORE GMBH
FDA registration
MAG & MORE GMBH·2 products·🇩🇪 Germany
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·October 8, 2025
K-ASSAY ALPHA-1 AG
FDA 510(k)
FDA Class 1
·Immunology
BAGS AND GLOVES CO., LTD.
FDA registration
BAGS AND GLOVES CO., LTD.·1 product·🇹🇭 Thailand
BAGS AND WRAPS ETC., INC.
FDA registration
BAGS AND WRAPS ETC., INC.·3 products·🇺🇸 United States
SCoV-2 Ag Detect Rapid Test
FDA 510(k)
FDA Class 2
·Microbiology
MEDICARE TAGS LIMITED T/A MEDYTRAK
FDA registration
MEDICARE TAGS LIMITED T/A MEDYTRAK·1 product·🇮🇪 Ireland
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
FDA 510(k)
FDA Class 2
·Immunology
ServiceSource - US Marine Corp Med Bags Program
FDA registration
ServiceSource - US Marine Corp Med Bags Program·5 products·🇺🇸 United States
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·September 2, 2025