8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
FDA 510(k)
FDA Class 1
·Microbiology
ENEMA BUCKET SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 3, 2024
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 10, 2014
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·November 22, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015