20 results
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21ms
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Sources: EU EUDAMED, US FDA
ADC QS/IPD WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151194·Endo Carry-on Procedure Kit contains Intercept ...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105710·Zirlux Multi-Unit Abutment 1.5 mmH compatible w...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450129951·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173565·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173534·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173541·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173589·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173572·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033173558·
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
GE LOGIQ 700
FDA 510(k)
FDA Class 2
·Radiology
BAUMER FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
TIBIAL ARTICULAR SURFACE PROVISIONAL
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·March 20, 2019
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·March 19, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 1, 2011
EPIC+ VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2008
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023
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