20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAUFLON MULTI LENS CARE SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151002·Endo Carry-on Procedure Kit contains Basin, VIA...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105590·Zirlux Titanium Screw compatible with: Nobel Bi...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450128442·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033169032·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033169049·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033169056·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033169025·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033169018·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033169001·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033219652·
ENGPLUS
FDA 510(k)
FDA Class 2
·Neurology
CALCIUM SULFATE PELLETS
FDA 510(k)
FDA Class 2
·Orthopedic
STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 12, 2022
SETROX S 60
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·March 19, 2013
TMJ MED LFT FOSSA COMP
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·March 8, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
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