21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Savion DLVR Guidewire, Savion FLX Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001162·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001827·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001155·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001780·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001179·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001797·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001803·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001810·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001834·MCK Inlay Tibial Component
VIDAS® MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·August 17, 2018
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197086042·DESCHAMPS Ligature Needle
210mm,...
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CALYPSO 4D LOCALIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AMISTEM P STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 13, 2020
BD ONCLARITY¿ HPV ASSAY REAGENT PACK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MAQ·December 26, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 20, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·July 22, 2011
VENTRICULAR BOLT ICP MONITOR KIT W/ CRANIAL ACCESS
FDA Adverse Event
Malfunction
·INTEGRA PAIN MGMT·Product code GWM·October 15, 2014
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020