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

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SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz

FDA 510(k)
FDA Class 2 ·Radiology

VAULT ALIF SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDILOG DARWIN HOLTER ANALYSIS

FDA 510(k)
FDA Class 2 ·Cardiovascular

OPTEASE

FDA Adverse Event
Injury ·CORDIS US CORP.·Product code DTK·April 24, 2024

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 26, 2024

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024

NEXGEN PROVISIONAL ARTICULAR SURFACE

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 8, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 8, 2013

EON MINI IPG, 16-CHANNEL RECHARGABLE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011

VANGUARD MONO FINNED STM TIB 71X14

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·December 9, 2024

VANGUARD ROCC TIB BRG UHMWPE 60X10MM

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 18, 2019

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023