15 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endoscopic Injection Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015375497·REVISION LOCKING SCREW L67.5MM D4.0MM
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015374995·REVISION LOCKING SCREW L67.5MM D4.0MM STERILE
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 10, 2018
AXIOM ARTIS U
FDA 510(k)
FDA Class 2
·Radiology
EMERGE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CURVE CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 9, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014