13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sklar
FDA UDI
SKLAR CORPORATION·10649111456923·SOLID COLOR SHEET TAPE PINK
ELECSYS IGE II IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
Follicle Aspiration Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
M2A-MAGNUM 42-50 TPR INSRT STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 12, 2017
MLRY-HD POR FMRL 14X175MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 12, 2017
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·July 24, 2021
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 22, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 15, 2011
ARCOMXL 36MM RINGLOC LINER HW SZ24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·July 28, 2014
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 12, 2017
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 12, 2017
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 6, 2016