20 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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