1,324 results · 30ms · Sources: EU EUDAMED, 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