31 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
FDA 510(k)
FDA Class 1
·Dental
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304462984·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260735·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009683·2.4mm x 12mm Cannulated Lag Screw
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198673·AK3 Ultra Insert Trial Size 4, 12mm
Orthos
FDA UDI
ORMCO CORPORATION·00889989030341·ORTHOS CM TMA 019 X 025 UPLG PK10
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070621·Cannulated 2.4 x 12mm Lag Screw Sterile Qty 5
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108108·TRIAL 90-SRK-192412 POLY-MPCS 4X12 LEFT
VISTA DIGITAL OPTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
STRONG IMPLANT HANDPIECES
FDA 510(k)
FDA Class 1
·Dental
M2A MAGNUM TAPER ADAPTOR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 10, 2017
M2A MAGNUM PF CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 6, 2017
ECHO POR FMRL RED NC 12X140MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 21, 2018
M2A-MAGNUM PF CUP 50ODX44ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 21, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2011
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 7, 2008
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 27, 2013
M2A-MAGNUM MOD HD SZ 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 20, 2018
32MM I.D. SIZE HH ELEVATED RIM LINER USE WITH 50MM O.D. SIZE HH SHELL
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·December 29, 2022
50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH HH LINERS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·December 29, 2022