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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system

FDA 510(k)
FDA Class 2 ·Orthopedic

CONCERT RADIOPAQUE BONE CEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

SAVANNAH TECHNOLOGIES SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

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

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·August 26, 2024

REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 13, 2023

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 24, 2024

SHOULDER - TINBN COATING

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·July 30, 2025

SHOULDER - TINBN COATING

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·September 17, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 19, 2025

REPLACEMENT TUBE

FDA Adverse Event
Malfunction ·ABBOTT NUTRITION·Product code KNT·October 22, 2008

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 16, 2011

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·September 24, 2021

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 10, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 18, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·September 19, 2024

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017