17 results · 29ms · Sources: EU EUDAMED, US FDA

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POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

3D

FDA UDI
Rmo, Inc.·00885797100153·3D LING ARCH ASST 30

CABLE,IBP HOSPIRA,IM2101,6PIN

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904005355·

ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS

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

REACH FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

MESH, SURGICAL

FDA Adverse Event
Injury ·W. L. GORE AND ASSOCIATES, INC.·Product code FTM·August 12, 2023

PANEL PHOENIX NMIC ID- 476

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 24, 2025

MESH - VENTRALEX

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 15, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·April 14, 2011

PERIFIX

FDA Adverse Event
Other ·B. BRAUN MEDICAL, INC.·Product code CAZ·July 1, 2008

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001073;

FDA Enforcement
Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022