13 results
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22ms
·
Sources: EU EUDAMED, US FDA
TSH RIASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031490·Rhoton® Dissector, Straight Point Needle, Etche...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130177·
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776355067·R-Type needle, straight,
LIFELINES PHOTIC STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
INOMAX DS (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 9, 2016
SYMMETRY RHOTON
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC·Product code GZX·April 19, 2023
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·April 25, 2014
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
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