13 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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ENDO-CHX
FDA 510(k)
FDA Unclassified
·Unknown
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004011·PowerChem Neoprene Exam Gloves, Extra Small
Restylane Vital 1 ML.
FDA UDI
LAMBSMEAD LTD·05060457760174·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694147·Pilot Guided Sleeve Ø2mm L5mm, L30mm Drill (Sil...
VAPOTHERM, MODEL 2000I
FDA 510(k)
FDA Class 2
·Anesthesiology
TRI-PLEX ADAPTER
FDA 510(k)
FDA Class 2
·Anesthesiology
COBRA PZF NANOCOATED CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·CELONOVA BIOSCIENCES, INC.·Product code MAF·August 21, 2017
STELLARIS 25GA POSTERIOR PACK W AFI & WF
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 17, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·June 30, 2008
T-PAL SMALL TEST IMPLANT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MAX·April 19, 2011
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