24 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEEDLE VIEW CH SCOPE KITS
FDA 510(k)
FDA Class 2
·Orthopedic
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331145704·operating scissors, blunt/blunt, straight, 6" (...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515065796·Roch Pean Fcps, cvd, 8"
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018532·Roch-Pean Hemo Fcps, cvd, 8"
MEDCOMMONS OPEN RADIOLOGY GATEWAY
FDA 510(k)
FDA Class 2
·Radiology
NMI IC
FDA 510(k)
FDA Class 2
·General Hospital
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 24, 2025
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 3, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·June 3, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 1, 2011
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·November 20, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·December 19, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 8, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 22, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·January 26, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·February 12, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·March 10, 2025
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
FDA Enforcement
Class II
·Terminated·Nidek Inc·September 4, 2013