12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO ENDOTINE RIBBON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TASMIN R 6°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014622·The basic shape of the TASMIN R devices is a ho...
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
FDA 510(k)
FDA Class 2
·Cardiovascular
CORAIL2 STD SIZE 13
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code MEH·April 16, 2013
LUPINE DOVE TAIL DRILL GUIDE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·March 11, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 16, 2008
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 6, 2026
PHENOM CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·April 6, 2026
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018