9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522123344·BLADDER COVER,ABP,STD ADULT,24-32 CM,QUICK DISC
KIPPMED I.V. MANIFOLD
FDA 510(k)
FDA Class 2
·General Hospital
SYNTHES VERTEBRAL SPACER TI
FDA 510(k)
FDA Class 2
·Orthopedic
ALIGN S URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTN·April 11, 2013
GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·June 11, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 15, 2011
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024