18 results · 28ms · Sources: EU EUDAMED, US FDA

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CONCEPT SWITCHING STICK

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978067728·INSTRUMENT 873-009 UCS CANN SCREWDRIVER

Innomed, Inc.

FDA UDI
INNOMED, INC.·00840277116437·Wrench for Nail Extractor

NCompass Nitinol Stone Extractors

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ONEPORT SURGICAL TROCAR SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

FDA Enforcement
Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 13, 2014

AUTOMATED PD SET W/CASSETTE4 PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 18, 2010

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 13, 2012

GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

FDA Recall
Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·April 1, 2022

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·April 1, 2022

UCSS

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·April 25, 2024

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·April 1, 2022

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·August 25, 2022

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·February 3, 2021

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Injury ·COOK INC·Product code LQR·January 8, 2025

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Injury ·COOK INC·Product code LQR·February 10, 2022