24 results · 22ms · Sources: EU EUDAMED, 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