21 results · 21ms · Sources: EU EUDAMED, 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