12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES SYNEX SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GentleYAG 6/8/10MM RGD Delivery System W/DCD
FDA UDI
Candela Corporation·00817495021553·Delivery System Assembly
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
FDA 510(k)
FDA Class 1
·General Hospital
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 12, 2024
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 24, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 12, 2014
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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