23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vitek Densichek
FDA 510(k)
FDA Class 2
·Microbiology
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 110mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036572·
Aspida
FDA UDI
ALPHATEC SPINE, INC.·00840967190921·LUMBAR DTS GUIDE 10MM
Orthos
FDA UDI
ORMCO CORPORATION·00889989030211·ORTHOS CM TMA ARCH 017X025 LOSM PK10
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463349·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260568·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198413·AK3 Ultra Insert Trial Size 1, 10mm
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419044·Integra® Miltex® Micro Ear Forceps 3" Shaft, Ov...
LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·February 23, 2024
24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN
FDA 510(k)
FDA Class 1
·Physical Medicine
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
FDA 510(k)
FDA Class 2
·Orthopedic
DUETTO MT
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·April 14, 2022
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819211000101·EXMRC Roth 022/UR1 12T 5A
EXPERIENCE
FDA UDI
Gc Orthodontics America Inc.·D78819211000071·Exp CCO RH 022/UR1 12T 5A
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819211000201·EXMRC MBT 022/UR1 17T 4A
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419051·Integra® Miltex® Micro Ear Forceps 3" Shaft, Ov...
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107910·TRIAL 90-SRK-192110 POLY-MPCS 1X10 LEFT
LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·November 22, 2023
G7 NEUTRAL ARCOMXL LNR 32MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·March 6, 2018
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 7, 2008