22 results · 23ms · Sources: EU EUDAMED, US FDA

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GammaTile

FDA 510(k)
FDA Class 2 ·Radiology

RESTORIS

FDA UDI
MAKO SURGICAL CORP.·00848486000646·MCK Femoral Component

MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 9 MM

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·July 20, 2023

MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·January 27, 2021

UCP DRUG SCREENING TEST CUPS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

FMRI HARDWARE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code OBJ·June 12, 2018

UNKNOWN MAKO ONLAY TUBE INSERT 010370

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code OLO·October 6, 2021

TIBIA INST-VITAMIN E-ONLAY SIZE5-8MM

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·May 25, 2017

MCK TIBIAL BASEPLATE-RM/LL-SZ 5

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·July 26, 2016

MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·February 10, 2025

MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·June 30, 2022

SERVO-I

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 15, 2014

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 20, 2013

EXTENSION SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 27, 2011

MCK TIBIAL BASEPLATE-RM/LL-SZ 5

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·October 3, 2017

MIDAS REX MR8

FDA Adverse Event
Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025

MOTOR MR8 ELECTRIC

FDA Adverse Event
Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022

MCK TIBIAL ONLAY INSERT-SZ 5-9MM

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·January 29, 2016

MCK TIBIAL ONLAY INSERT-SZ 6-8MM

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code NPJ·April 10, 2017