23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PREMIUM
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014011·Zirlux 16+ A3.5 98.5X20
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613072025·Tissue Forceps, 1 x 2 Teeth, Overall Length 5" ...
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112300·Tap, 8.5mm Cortical, SNI1
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 11, 2025
3D MANUAL COARSE MANIPULATOR MN-188NE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·October 8, 2025
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·October 8, 2025
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·October 8, 2025
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·October 8, 2025
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·October 8, 2025
PFN 011 130 DEGREE L240 TAN GREEN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDW·February 9, 2012
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 19, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 8, 2011
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 3, 2021
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011