21 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYNTHES ANTEROLATERAL CALCANEAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105181·Zirlux Guide Pin
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150715·Endo Carry-on Procedure Kit contains Intercept ...
FRANK MUELLER
FDA registration
FRANK MUELLER·8 products·🇩🇪 Germany
MIO ADVANCE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·August 13, 2025
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033169193·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033191040·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033169216·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033169209·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033169186·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033191033·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033169230·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
GRADIA
FDA 510(k)
FDA Class 2
·Dental
MACROPRO GEL
FDA 510(k)
FDA Unclassified
·Unknown
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013
ZIMMER M/L TAPER KINECTIVE FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LWJ·March 1, 2011
SUPER MULTIVAC 50
FDA Adverse Event
ARTHROCARE CORPORATION·Product code GEI·February 11, 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
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