14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cordera Hip System Offset Cup Impactor, Enztec
FDA UDI
Conformis, Inc.·00810933031114·Offset Cup Impactor, Enztec
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182147·
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 17, 2025
AT HOME DRUG TEST, MODEL 9083 T
FDA 510(k)
FDA Unclassified
·Unknown
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VACUTAINER® EDTA 2K
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·January 5, 2023
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 23, 2026
BD VACUTAINER® EDTA 2K
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 28, 2022
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 26, 2013
ENDOTAK ENDURANCE
FDA Adverse Event
Death
·CPI - DEL CARIBE·Product code NVY·May 6, 2011
STERLING MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQY·July 22, 2008
1080-646 OFFSET CUP IMPACTOR (BODY) ED-06068 & OFFSET CUP IMPACTOR TRINKET ED-06
FDA Adverse Event
Malfunction
·CONFORMIS, INC·Product code LXH·December 7, 2023
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