52 results · 41ms · Sources: EU EUDAMED, 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