12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KELES FACEMASK
FDA 510(k)
FDA Class 2
·Dental
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
MILLENNIA ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
COCR FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·February 23, 2018
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·April 8, 2013
PULSAR MAX II
FDA Adverse Event
Injury
·GUIDANT CLONMEL IRELAND·Product code NVZ·April 6, 2011
VITALITY 2 DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
BD QUINCKE SPINAL NEEDLES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code BSP·September 29, 2023
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018