52 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Regenerex
FDA UDI
Biomet Orthopedics, LLC·00880304506084·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515065901·Roch-Ochs Hemo Fcps, str, 1x2 tth, 9 1/2"
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613102449·Hartmann Infant Speculum, Round, 2.5mm Diameter...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018761·Roch-Ochs Hemo Fcps, str, 1x2 tth, 9 1/2"
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VENOJECT LUER ADAPTER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·June 3, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 1, 2011
9600EMI
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
VANGUARD COMPLETE KNEE SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 13, 2017
REGENEREX TIBIAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·July 13, 2017
MICROPLASTY TIBIAL TRAYS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 13, 2017
VANGUARD COMPLETE KNEE SYSTEM
FDA Adverse Event
Injury
·.·Product code JWH·July 13, 2017
VANGUARD COMPLETE KNEE SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 13, 2017
REGENEREX TIBIAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·July 13, 2017
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
FDA Recall
Terminated
·Biomet, Inc.·Product code MBH·April 17, 2020
VANGAURD CR FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 28, 2018
VANGUARD CR TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 27, 2018
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 3, 2020