92 results · 24ms · Sources: EU EUDAMED, US FDA

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Bose SoundControl Hearing Aids

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

EASYPOINT NEEDLE

FDA Adverse Event
Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

EASYPOINT NEEDLE

FDA Adverse Event
Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

NA

FDA UDI
Smith & Nephew, Inc.·03596010543615·DYONICS 25 PATIENT TUBE SET MUST ...

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193114392·HA PEEK EVOS Straight, ,8mmx11mmx 30mm , FLAT ...

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551110330·HALO, 1203-5 VEST PED00, COOLMAX LINER, 1211-1 ...

Zavation

FDA UDI
Zavation LLC·00842166132603·Ti3Z CIF 13mmx15mmx8mm -10 deg

Biliary Drainage Tube

FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046957·

TRILLIANT SURGICAL K-WIRES

FDA 510(k)
FDA Class 2 ·Orthopedic

MICROWARE BONE PLATES AND BONE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2025

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 13, 2011

LUMAX 640 VR-T DX PROMRI

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·October 29, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2024

DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field.

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HRX·August 7, 2008

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2025

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025