14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EUROIMMUN ANTI-M2-3E ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018
MONOJECT SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
HEART 2006
FDA 510(k)
FDA Class 2
·Cardiovascular
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·September 6, 2023
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
Kit BD Max GC RT PCR Assay; Catalog # 443486
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 3, 2013
HS III PROXIMAL SEAL SYTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 20, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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