4,581 results
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42ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA UDI
Fehling Instruments GmbH & Co. KG·04058749024432·TC De Bakey needle holder straight 180 mm
J7P GJ MEDICAL CHAIR
FDA Adverse Event
Malfunction
·KAG INDUSTRIES·Product code KMN·April 24, 2002
ROCHE CARDIAC, TROPONIN T QUANTITATIVE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·December 8, 2014
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO., KAG·Product code NVZ·December 16, 2011
LAZIC
FDA Adverse Event
Malfunction
·PETER LAZIC GMBH MICROSURGICAL INNOVATIONS·Product code KAG·December 19, 2023
6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code MGB·June 14, 2021
ALLURA XPER FD10
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·December 21, 2018
CARDIOHELP
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·June 4, 2025
CARDIOHELP
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·June 4, 2025
Holder, Speculum, Ent
FDA classification
FDA Class 1
·Holder, Speculum, Ent
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
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
KAL-MED, LLC.
FDA registration
KAL-MED, LLC.·2 products·🇺🇸 United States
MACO BAG CORP.
FDA registration
MACO BAG CORP.·2 products·🇺🇸 United States
KAI INDUSTRIES CO., LTD.
FDA registration
KAI INDUSTRIES CO., LTD.·9 products·🇯🇵 Japan
KAI XING OPTICAL LIMITED
FDA registration
KAI XING OPTICAL LIMITED·4 products·🇨🇳 China
K-ASSAY ALPHA-1 AG
FDA 510(k)
FDA Class 1
·Immunology
Pylant Monitor
FDA UDI
Kal-Med, LLC·00860010850909·Pylant Monitor - Disposable endotracheal tube c...
BAGS AND GLOVES CO., LTD.
FDA registration
BAGS AND GLOVES CO., LTD.·1 product·🇹🇭 Thailand
E-Kai Industrial Co., Ltd.
FDA registration
E-Kai Industrial Co., Ltd.·3 products·🇨🇳 China