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