9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BUFFERED CHARCOAL YEAST EXTRACT AGAR
FDA 510(k)
FDA Class 1
·Microbiology
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ONCOLOGY SALVAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RHK SEGMENTAL SHORT YOKE
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·December 7, 2016
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
ACCU-CHEK ® ADVANTAGE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 24, 2012
VERSA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·August 17, 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