21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Patient Monitor: RespArray
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220308150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220308000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220308070·
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569684·CoRoent Ant TLIF Ti, 12x10x30mm 8°
DEXCOM G6 SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·March 29, 2022
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506082542·3MM DIA., BLUNT TROCAR, 70MM LENGTH
ELMED
FDA UDI
ELMED INCORPORATED·00842180182394·REDUCER CANNULA; 5MM TO 3MM X 170MM, W/ 3MM SEA...
REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MTS Lefamulin 0.016- 256 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 16, 2022
FLOWFLEX COVID-19 ANTIGEN HOME TEST
FDA Adverse Event
Malfunction
·ACON LABORATORIES, INC.·Product code QKP·January 4, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 30, 2021
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 3, 2014
OPTIVANTAGE BASE SYSTEM
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·August 16, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
SOFTWARE CSS7200 GRDN IOS APP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·August 24, 2024
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 14, 2022
Identity Shoulder System Resection Planer 35mm Resection Planer
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·February 15, 2023
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022