16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496063377·SOCKS FOR YOU BAMBOO SQUARE, SIZE XXL, NERO, GR...
BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
FERMIT N PLUS
FDA 510(k)
FDA Class 2
·Dental
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·April 11, 2013
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·June 19, 2008
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·May 20, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 23, 2022
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 19, 2025
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015