13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450206980·
300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
FDA 510(k)
FDA Class 2
·Radiology
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 30, 2026
NEEVA BABY FETAL DOPPLER
FDA Adverse Event
Injury
·CONTEC MEDICAL SYSTEM CO., LTD.·Product code KNG·October 27, 2020
SONOLINE B (FETAL DOPPLER)
FDA Adverse Event
Injury
·BABY DOPPLER / DAGAMMA INC.·Product code HGM·January 17, 2019
OPT BL VP V2 5MM STD W/FX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GCJ·April 22, 2013
ZIMMER NATURAL NAIL SYSTEM CANCELLOUS SCREW
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSB·May 3, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 25, 2008
BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·September 15, 2021
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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