10 results · 19ms · Sources: EU EUDAMED, US FDA

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Veinoflow SCD (Model: LBTK-M-I 5006)

FDA 510(k)
FDA Class 2 ·Cardiovascular

MOLECULAR ADSORBENT RECIRCULATING(MARS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 30, 2014

COLLEAGUE PRE-P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

FDA Adverse Event
Injury ·BARD SHANNON LIMITED·Product code FTL·July 2, 2013

CustMbite, Model Number CBT-SRS-UL

FDA Enforcement
Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

LIFE SCOPE G9

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024

LIFE SCOPE G9

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023

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