16 results
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30ms
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Sources: EU EUDAMED, US FDA
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
FDA 510(k)
FDA Class 2
·Cardiovascular
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160562·Channels Flex21mm 20.04
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717108108·Paper Points, Taper .06 Size #15-#40, 100pcs/box
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
FDA 510(k)
FDA Class 2
·Orthopedic
BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 15, 2018
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·March 26, 2013
DELTA UNITIZED SHUNT, SMALL, PERFORMANCE LEVEL 1.5
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·February 10, 2011
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008
BD LUER-LOK 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 7, 2019
MARKSMAN
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code KRA·November 6, 2025
BD LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 27, 2019
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 30, 2023
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018