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

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INTEGRA LAMINOPLASTY SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925016866·WILLIAMS MICROCLIP INSERTER

MTAPE 1.5"X10 YARD

FDA UDI
Mueller Sports Medicine, Inc.·00074676138305·MTAPE 1.5" X 10YD TEAMPAK PINK

M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

B. BRAUN NERVE BLOCK CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

VERCISE GENUS?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·July 4, 2025

MAGNUM M2A RECAP CUP

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 24, 2026

MAGNUM M2A

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 24, 2026

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 24, 2013

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014

DA+ C SERIES DR

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code DXY·June 16, 2011

Core Biopsy Tray Catalog Number: 8673R4

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Various products which were contract sterilized.

FDA Enforcement
Class II ·Ongoing·Anewmed Corporation·November 6, 2019

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018