1,324 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VISION ONE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018600962·This product is an orthodontic bracket and is u...
GRANDIO FLOW
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
ADAPTA SR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·June 2, 2011
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 2, 2016
YAMATO PLUS-R 7.5FR. 30CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 4, 2021
TRANS-RAY PLUS 7.5 FR. 40CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·August 26, 2021
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 2, 2016
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·December 16, 2021
CARDIOSAVE HYBRID TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·July 21, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 2, 2019
UNKNOWN INTRA-AORTIC BALLOON
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 21, 2021
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·November 16, 2016
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 8, 2016
UNKNOWN INTRA-AORTIC BALLOON
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·November 22, 2021
HST III SYSTEM (4.3MM)
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code DXC·November 16, 2021