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