20 results · 26ms · Sources: EU EUDAMED, US FDA

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INTEGRITY(TM)

FDA 510(k)
FDA Class 2 ·Radiology

PINNACLE®

FDA UDI
B. BRAUN MEDICAL INC.·04046955772803·SCB 3000ML EVA MIXING CONT. SINGLE PACK

1240 1 WAY VALVE

FDA UDI
HANS RUDOLPH, INC.·00874750009190·1240C 1WAY 22MMOD/15MMID PORTS

Trephine

FDA UDI
ELLIQUENCE, LLC·00846338002343·

InFill Lordotic TLIF

FDA UDI
PINNACLE SPINE GROUP, LLC·00814729025080·

Spine Innovation Interbody System

FDA UDI
SPINE INNOVATION, LLC·00817722020335·Expandable Implant 5° x 11mm W x 13mm H x 26mm L

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

REPROCSSED LINVATEC SHAVERS

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 7, 2023

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

FRESENIUS LIBERTY CYCLER

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·September 10, 2014

PINN SECTOR W/GRIPTION 56MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 19, 2011

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 8, 2019

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

FDA Enforcement
Class II ·Terminated·ConMed Corporation·April 4, 2018

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

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