19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERDICT -II BAR/BZO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151026·Endo Carry-on Procedure Kit contains Intercept ...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036008321·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033172193·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0100610·Caddie Lid, Modular Bone Screws
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033172223·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033172216·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033172230·
MINMED QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 16, 2025
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·June 9, 2010
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARDIOMEDICS ECP SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 7, 2023
R SERIES DEFIBRILLATOR
FDA Adverse Event
Death
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 11, 2013
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·COOK UROLOGICAL INC·Product code GEX·March 1, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·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