23 results · 26ms · Sources: EU EUDAMED, US FDA

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ConforMIS iTotal Posterior Stabilized Knee Replacement System

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

Sklar

FDA UDI
SKLAR CORPORATION·10649111451829·TC METZENBAUM THOREK SCISSORS

LITE-MED LM-9200 ELMA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148

FDA 510(k)
FDA Class 2 ·Cardiovascular

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·June 3, 2019

JOURNEY FEM OX NP BCS LT SZ 7

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 8, 2014

CAPSURE SP

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 8, 2013

VASOVIEW HEMOPRO 2 EVH SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·June 17, 2011

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·July 24, 2019

TIBIAL INSERT FB SZ 3 RT 10MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·April 13, 2023

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022