8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SERA-PAK TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 1
·Hematology
SPHYGMOCOR MX MODEL SCOR-MX
FDA 510(k)
FDA Class 2
·Cardiovascular
NASAL CEASE
FDA 510(k)
FDA Unclassified
·Unknown
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 9, 2014
PWRD ECH FLEX 60MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 24, 2012
MP30 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 9, 2010
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