16 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608143·STERIS SURGI-GRAPHIC 6000 2.25" SOFTCARE PLUS
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179857·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450259924·
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
MERIDIAN-PORTABLE
FDA 510(k)
FDA Class 2
·Neurology
BD ULTRA-FINE¿ PRO PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 13, 2023
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022
RELION INSULIN SYRINGES 3/10ML 31 GAUGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 19, 2022
NEXGEN CR PROLONG ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code JWH·April 24, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 6, 2011
UNKNOWN DEPUY METAGLENE SCREW
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code HSD·July 22, 2008
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
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