19 results · 20ms · Sources: EU EUDAMED, US FDA

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Amis K Long

FDA 510(k)
FDA Class 2 ·Orthopedic

MECTACER BIOLOX OPTION HEADS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025

CoRoent

FDA UDI
Nuvasive, Inc.·00887517629715·CoRoent Ant TLIF Ti, 12x10x40mm 15°

ambIT

FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005176·Pain Control Kit - Basic with 420 mL MediBag an...

ambIT*

FDA UDI
Avanos Medical, Inc.·00193494000967·ambIT* Pain Control Kit - Basic w/420mL MediBag...

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00842180157682·LAPAROSCOPIC PORT CLOSURE GUIDE, 5MM DIA., 10 C...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540365300·Bone Screws, Cross-Pin

BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1

FDA 510(k)
FDA Class 2 ·Cardiovascular

WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·August 23, 2011

PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 4, 2008

ATLAS PLUS VR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

SKINTACT

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

EasyPoint Needle, 25G x 5/8", REF: 82091

FDA Enforcement
Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

FDA Enforcement
Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025