10 results
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26ms
·
Sources: EU EUDAMED, US FDA
COSMATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040049228·Band Biter
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
CONTINUUM TM SHELL WITH CLUSTER HOLES
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LZO·April 5, 2013
EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·March 11, 2011
PADPRO
FDA Adverse Event
Other
·KATECHO·Product code MLN·June 12, 2008
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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