13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
FDA 510(k)
FDA Class 2
·Anesthesiology
SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
FDA 510(k)
FDA Class 1
·Dental
MOBIUS ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 16, 2023
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·June 20, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 15, 2022
HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·May 21, 2018
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013
MIS QUAD-SPARING FEMORAL INSERTER/EXTRACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HWA·May 26, 2011
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·October 5, 2014
ESOPHYX Z
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017
ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014