22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VIGIL SEROLOGY CONTROL LEVEL C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150166·Endo Carry-on Procedure Kit Includes Intercept ...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890103580·Zirlux Bite Ver Cyl Non Eng
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033142493·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033142547·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033142523·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033142509·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033142530·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033142516·
YPSOPUMP INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·April 24, 2025
MULTI ADJUSTABLE FACE MASK
FDA 510(k)
FDA Class 2
·Dental
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 4, 2025
PROFEMUR(R) HIP STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
LIPOSONIX SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC.·Product code OHV·March 19, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·March 8, 2011
IRRAFLOW
FDA Adverse Event
Injury
·IRRAS USA INC.·Product code JXG·September 18, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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