11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ARx Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Anti-Human Globulin Anti-IgG - Clear
FDA UDI
DIAGAST·23661562105490·Anti-Human Globulin Anti-IgG (Murine Monoclonal...
ELMED
FDA UDI
ELMED INCORPORATED·00842180107472·5 MM DIA., 45 CM INSULATED SLING TIP ELECTRODE,...
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENSITE VELOCITY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 10, 2011
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KSZ·July 24, 2008
UNIFY ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·November 18, 2024
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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