21 results · 23ms · Sources: EU EUDAMED, 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