15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033539958·
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601204·This product is an orthodontic bracket and is u...
COMPR SRS MOD RGX AUG - SM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·June 1, 2022
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
ACE HA SCREW DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·November 5, 2008
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·August 17, 2011
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 11, 2013
PUMP MMT-1711KL 640G V4.10 BK SF MM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 23, 2021
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016