19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XPS 3000 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACP
FDA UDI
Nuvasive, Inc.·00887517062536·ACP 2.1H Plate, 73mm 3-Level
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151705·Endo Carry-on Procedure Kit contains Intercept ...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890106770·Zirlux Bite Ver Cyl Non Eng
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450133361·
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·August 21, 2025
BD 10 ML LL SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·August 3, 2022
BABY DOPPLEX 4000 (BD4000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZUMA GUIDE CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
BD¿ PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 13, 2022
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code MUZ·March 19, 2013
TI 3-D HEAD FOR TI CLICK 'X SCREWS
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MNH·February 25, 2011
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
ANGIO-SEAL DEVICE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·June 8, 2012
ZUMA Z2 7F GUIDE CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC, INC·Product code DQY·June 12, 2020
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
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