13 results
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19ms
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Sources: EU EUDAMED, US FDA
STOCKINETTE, STERILE TWO PLY W/PULL TABS
FDA 510(k)
FDA Class 1
·General Hospital
ACUMED
FDA UDI
Acumed LLC·10806378049576·Midshaft Forearm Hexalobe Screw Lid
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776336615·In-Situ Bypass Hooks
Symmetry Verity™
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031087·Verity Hook, Nerve, Titanium Handle, 2.0 mm Blu...
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DYNA-LOK CLASSIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICROBALL HOOK
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, INC.·Product code GDG·September 25, 2024
VERITY HOOK, NERVE, 2.0 MM BLUNT TIP
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC.·Product code GDG·November 26, 2024
VERITY HOOK, NERVE, TITANIUM HANDLE, 2 MM TIP, 7 1/4 INCH SHAFT
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC.·Product code GDG·October 14, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
EASYPUMP: LT 270-24: 270ML, 10ML/HR
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code MEB·October 18, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 16, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021