9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 29, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015