16 results · 21ms · Sources: EU EUDAMED, US FDA

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VSI Micro-Introducer Kit

FDA 510(k)
FDA Class 2 ·Cardiovascular

IQVITALS AND IQVITALS SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·July 7, 2011

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·September 23, 2008

M2A-MAGNUM PF CUP 56ODX50ID

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 15, 2025

M2A-MAGNUM MOD HD SZ 50MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 15, 2025

M2A-MAGNUM 42-50 TPR INSRT STD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 15, 2025

SINGLE USE GUIDWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 29, 2020

SINGLE USE GUIDWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020

SINGLE USE GUIDWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020

SINGLE USE GUIDWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 24, 2020

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code MIH·October 18, 2019

ROSA Brain 3.0 Application-Brain

FDA Enforcement
Class II ·Terminated·MEDTECH SAS·February 19, 2020

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

FDA Enforcement
Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022