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

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HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST

FDA 510(k)
FDA Class 1 ·Dental

TruForm

FDA UDI
Rmo, Inc.·00885797099815·MX 1-2 BI BD KT N/L UNIV 131

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020402·CELL-BOND Slides, 1 Well, blue background

iQ®200

FDA UDI
BECKMAN COULTER IRELAND INC.·10837461002345·iQ® Body Fluids Controls-Level I and Level II (...

VS600/900 Rolling stand

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904091693·

MINMED QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·August 20, 2024

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ASSURE WEARABLE CARDIOVERTER DEFIBRILLAT

FDA Adverse Event
Malfunction ·KESTRA MEDICAL TECHNOLOGIES, INC.·Product code MVK·November 26, 2025

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·February 22, 2011

ACCU-CHEK SPIRIT CARTRIDGE

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 20, 2008

ADVIA CENTAUR XP CA 19-9 ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NIG·February 5, 2016

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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