13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEB-90 LARGE VOLUME MEDICATION NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
Cordera Hip System Radel Liner Impactors 36mm
FDA UDI
Conformis, Inc.·00810933031206·Radel Liner Impactors 36mm
LUER ACCESS UNIVERSAL VIAL ADAPTER
FDA 510(k)
FDA Class 2
·General Hospital
COPELAND MB RESURFACING HUMERAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
INFINION? CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 25, 2026
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·October 16, 2018
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 16, 2018
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·October 16, 2018
PINN CAN BONE SCREW 6.5MMX45MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·April 26, 2013
NATURAL KNEE HIGH TIBIAL LOCATING NEEDLE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HAW·April 26, 2011
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 22, 2008
HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013
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