12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EndyGel
FDA 510(k)
FDA Class 2
·Neurology
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD671617150·Fiber Optic Light Carrier 15cm
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071102142·16FR x 1.7 cm x 15 cm Low Profile Transgastric-...
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071134662·16FR x 1.7 cm x 15 cm Low Profile Transgastric-...
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MRGFUS GENERAL PURPOSE AND BREAST COIL
FDA 510(k)
FDA Class 2
·Radiology
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071134679·16FR x 1.7 cm x 15 cm Low Profile Transgastric-...
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071117085·16FR x 1.7 cm x 15 cm Low Profile Transgastric-...
OCTRODE
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 8, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024