20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304232334·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868248085·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558924·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321415160·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613068516·Shapleigh Curette, Small, Very Delicate 1.5mm S...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613021405·Shapleigh Curette, Large, Very Delicate 2mm Ser...
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101895·Poly Insert MPCS, Size 5R, 16mm
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
VANGUARD FEMORAL POSTERIOR AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018
VANGUARD FEMORAL POSTERIOR AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018
VANGUARD FEMORAL DISTAL AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018
VANGUARD SSK INTERLOK FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
VANGUARD POSTERIOR STABILIZED TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
BIOMET SPLINED KNEE STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015