16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017934·K-Wire, Double Ended, Trocar Point, Diameter Si...
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029041925·2 Upper Bicuspid Extraction
CETRA
FDA UDI
Orthofix US LLC·18257200120499·2-LEVEL PLATE ASSEMBLY, 54MM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804373·Cottle Periosteal Elevator, Slightly Curved, 4m...
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
FDA 510(k)
FDA Unclassified
·Unknown
GOLDEN COMFORTER
FDA Adverse Event
Malfunction
·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012
GORE DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 21, 2014
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 10, 2013
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020