13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTEX(r) Reconstruction System
FDA 510(k)
FDA Class 2
·Orthopedic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284072·
BREATHSCN PRO
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SOLAR GI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVANCE
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code DXE·September 9, 2019
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·January 13, 2014
G4 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 7, 2013
SYNCHRON CX5 DELTA CLINICAL ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·June 24, 2011
Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024