13 results · 28ms · Sources: EU EUDAMED, US FDA

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BruxZir® Radiant

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257130117·30-40 MV FOR MEN CLSC EW STD BLACK IV

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257128565·30-40 MV FOR MEN SEL EW CLF STD BLK IV

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017996·K-Wire, Single Ended, Trocar Point, Diameter Si...

GALILEO GOLD

FDA 510(k)
FDA Class 2 ·Anesthesiology

EksoNR

FDA 510(k)
FDA Class 2 ·Physical Medicine

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

BD EMERALD¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 3, 2018

6875 HANA OPERATING ROOM TABLE

FDA Adverse Event
MIZUHO OSI·Product code JEA·August 24, 2011

SENSOR ENLITE

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZO·November 10, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 2013

PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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. 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

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021