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

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SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

2130 3 WAY STOPCOCK

FDA UDI
HANS RUDOLPH, INC.·00874750009343·2130A 3W STPCK .187FB 7.5MMOD

SPIDER FLEX MONOPOLAR HOOK

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TERUMO 30 GAUGE HYPODERMIC NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

AQUILEX FLUID CONTROL SYSTEM

FDA Adverse Event
Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

MAINFRAME 8253001 NIM RESPONSE 3.0

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 19, 2011

PROXIMATE PPH PROCEDURE SET

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 11, 2008

NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

NIM® 3.0 MAINFRAME

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

NIM® 3.0 MAINFRAME

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

NIM® PROBE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

NIM® PROBE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015

MPACT DM CONVERTER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 21, 2025

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

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