15 results
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19ms
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Sources: EU EUDAMED, US FDA
MULTI-USE ELECTRONIC PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"
MEDLINE STERISET STERILIZATION CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 5, 2013
OMNISPAN MENISCAL FASTENER, 12 DEGREE NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 11, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·June 16, 2008
UNKNOWN BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017
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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022