21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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