12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BUDDE-HALO RETRACTOR
FDA 510(k)
FDA Class 2
·Neurology
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435062230·MCD Screw 3.0 x 32 mm cannulated M2
partia...
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
FDA 510(k)
FDA Class 2
·Neurology
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·May 23, 2014
MST8 FINAL ASSY JRZ
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·October 26, 2007
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 13, 2012
PEDIC-SCR-MATR 5.5 Ø7 L45 TAN
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·September 10, 2013
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·June 2, 2024
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·September 30, 2024
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·February 12, 2025
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015