21 results · 25ms · Sources: EU EUDAMED, US FDA

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Tibia and Fibula System

FDA 510(k)
FDA Class 2 ·Orthopedic

CONTIPLEX FX

FDA 510(k)
FDA Class 2 ·Anesthesiology

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

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

KNEE-DUMMY IMPLANT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

UNKNOWN KNEE DEVICE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

UNKNOWN KNEE DEVICE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC·Product code JWH·September 30, 2018

75MM SELECTABLE NEW TLC

FDA Adverse Event
Death ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2011

WAVELIGHT EX5000 EXCIMER LASER

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·October 24, 2014

ENDOTAK C

FDA Adverse Event
Injury ·HISTORICAL CPI ST. PAUL·Product code NVY·July 9, 2013

SHOULDER SYSTEM

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

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 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·October 22, 2025

GLENOID RECONSTRUCTION SYSTEM

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

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026

ALINITY I TOXO IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·November 18, 2024

REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021

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