13 results · 26ms · Sources: EU EUDAMED, US FDA

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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