16 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Carestream DRX-1 System
FDA 510(k)
FDA Class 2
·Radiology
AGXO
FDA UDI
Oticon A/S·05707131282064·H150V2, MINIBTE 312 WL 85 STG AGXO
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962161968·WEISMAN PEDERSON, RIGHT SIDE OPENING, LARGE
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 23, 2024
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
TOTAL ASR ACET IMP SIZE 56
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013
STEALTH INAV PORTABLE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 21, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 6, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 15, 2020
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·September 21, 2021
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 9, 2023
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·December 6, 2024
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020