22 results · 23ms · Sources: EU EUDAMED, US FDA

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TGL FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743588·LEVAMED ANKLE SUPPORT SAND I

X-Guide

FDA UDI
XNAV TECHNOLOGIES LLC·00817421021237·TRACKER ARM ASSEMBLY, EDX, ANTERIOR UR

Medallion®

FDA UDI
Merit Medical Systems, Inc.·00884450543924·

SMI MEDICAL INSTRUMENTS GMBH & CO.KG

FDA registration
SMI MEDICAL INSTRUMENTS GMBH & CO.KG·24 products·🇩🇪 Germany

INSET

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 10, 2026

INSET II

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·November 24, 2025

INSET

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 10, 2026

DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER

FDA 510(k)
FDA Class 2 ·Orthopedic

THINKINGNET

FDA 510(k)
FDA Class 2 ·Radiology

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 2, 2025

CM ALVIM IMPLANT 5.0X13

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·March 16, 2018

MERIT CUSTOM KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code FMF·March 14, 2013

EZ-28 DELIVERY SYSTEM

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code MSS·March 3, 2011

QUICKSITE LV

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

CHLORAPREP ONE STEP

FDA Adverse Event
Injury ·Product code KXG·August 23, 2021

DREAMSTATION AUTO CPAP

FDA Adverse Event
Death ·RESPIRONICS, INC.·Product code BZD·January 8, 2024

BD ANGIOCATH¿ IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·January 17, 2018

CHLORAPREP UNKNOWN

FDA Adverse Event
Injury ·CAREFUSION 213, LLC 0113·Product code OJU·August 25, 2021

Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011