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

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Disposable Surgical Gown

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

KANEDA SR

FDA UDI
Medos International Sàrl·10705034005232·KANEDA SR ANTERIOR SYSTEM ANGLED AWL (MODULAR)

Zavation

FDA UDI
Zavation LLC·00842166132221·Ti3Z CIF 13mmx15mmx10mm -5 deg

TO BE ASSIGNED

FDA UDI
FGX INTERNATIONAL INC.·00193033540022·

Laport

FDA UDI
Sejong Medical Co., Ltd·08806182210372·

S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SYRINGES 0.3ML 31GA 8MM

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 24, 2020

RELION INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 22, 2020

HAMILTON-G5

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·March 3, 2023

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025

RELION INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 2, 2020

GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·October 18, 2023

GMK HINGE AND REVISION TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2025

GMK HINGE AND REVISION TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025

GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·March 22, 2024

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

FDA Enforcement
Class II ·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021

LCS COMP RP INSERT STD+ 12.5MM

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC·Product code NJL·October 22, 2008

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 9, 2011

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013