45 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304213074·
P&P needle guide for "Multi Hub Assembly"
FDA UDI
Noras MRI products GmbH·04251269202322·
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003624·76 V2 ASSY SMALL 22ID NO HG
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493988·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045616·Wedge Distractor, 12mm
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795004836·
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
TRINON Q & Q3 IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 10, 2013
CAD II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 24, 2014
HI-TORQUE PILOT GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·June 3, 2011
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2022