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

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RAILWAY Sheathless Access System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Handle

FDA UDI
I.T.S. GmbH·09120047308233·Handle, Cannulated Tibia Nail

OsteoMed

FDA UDI
OSTEOMED LLC·00845694005067·Medium 2 Hole Straight Plate, Rigid

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668100943·JAFFE LID RETRACTOR SMALL

OsteoMed

FDA UDI
OSTEOMED LLC·00845694065429·1.6 System 2 Hole Medium Straight Rigid Plate S...

ENTEROSCOPY OVERTUBE, MODEL 00712140

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

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 27, 2011

EPOLY RLC 36MM 10DEG SZ26

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·June 20, 2013

CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·September 26, 2008

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 13, 2021

REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 5, 2023

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022

SHOULDER SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·December 2, 2024

ANATOMIC SHOULDER PROSTHESIS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·May 23, 2025

REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·January 12, 2022

REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 25, 2021

ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·September 21, 2021

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022