12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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elance Vital Signs Monitor, Central Monitor Software
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131287403·H11V2, MINIRITE 312 WL CNB
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820076·Marina Dissector, 10mm Langenbeck Chisel Tip, S...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450326190·
SURGISEAL TOPICAL SKIN ADHESIVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·May 30, 2013
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 7, 2011
TRUE METRIX AIR
FDA Adverse Event
Injury
·TRIVIDIA HEALTH INC·Product code NBW·April 26, 2021
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024