31 results · 26ms · Sources: EU EUDAMED, US FDA

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QUICKVUE RSV 10

FDA 510(k)
FDA Class 1 ·Microbiology

Tibial Spacer

FDA UDI
ADLER ORTHO SPA·08052693620883·LB H 18 mm TIBIAL SPACER

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964071379·The ENDO CARRY-ON Procedure Kit contains all of...

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·47291046346691·Rotary diamond instrument for dental application

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046257901·Rotary diamond instrument for dental application

NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

KSEA PERCUTANEOUS FORAMINOSCOPY SET

FDA 510(k)
FDA Class 2 ·Orthopedic

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
LAND AMERICA HEALTH & FITNESS·Product code FSA·September 19, 2014

SOLETRA

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·May 18, 2011

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020

LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 6, 2025

LOGIC FEMORAL PS CEM RIGHT SZ 2

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 25, 2022

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019

Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

FDA Enforcement
Class II ·Ongoing·Gentell, Inc·April 8, 2020