10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SPOR-O-THERM
FDA 510(k)
FDA Class 1
·Microbiology
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001286·VITROS Immunodiagnostic Products Anti-HAV Total...
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARESIDE HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
TOTAL ASR FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 9, 2014
GORE EXCLUDER AAA ENDOVASCULAR
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012