22 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306813672·Magill Endotracheal Catheter Intro Forceps, 17c...
MCC-MIV ONE 2 ONE SOFTWARE
FDA 510(k)
FDA Class 2
·Physical Medicine
ACCU-CHEK COMPLETE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XIA LP POLYAXIAL SCREW 6.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
XIA ROD DIA. 6 X 480
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011
XIA BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011
XIA SCREW 6, 5 X 40
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011
XIA LP POLYAXIAL SCREW 5.5 X 45MM
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016
XIA POLYAXIAL SCREW 8.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011
XIA BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 11, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 4, 2014
ONE TOUCH ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·June 17, 2008
BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 7, 2022
XIA LP POLYAXIAL SCREW 6.5 X 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 21, 2021
BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 3, 2021
ALARIS® PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION·Product code FRN·October 31, 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