13 results
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26ms
·
Sources: EU EUDAMED, US FDA
ORGANON ARTERIAL BLOOD SAMPLER
FDA 510(k)
FDA Class 1
·Anesthesiology
MAGNIFIER LENS
FDA UDI
KATENA PRODUCTS, INC.·00841668111628·
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209125463·
IMIX PANORAD AND SOMARAD
FDA 510(k)
FDA Class 2
·Radiology
VIKING OPTIMA GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 11, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015
ABC HANDPIECE LAPAROSCOPIC
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019
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