42 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXTRON 3; EXTRON 5; EXTRON 7
FDA 510(k)
FDA Class 2
·Radiology
XLIF
FDA UDI
Nuvasive, Inc.·00195377160034·XLIF Prone Retractor Level
OSE
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042122376·Super Elastic Nickel Titanium Archwires Natural...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192732·Modular Peg Drill - Zimmer
K-SPONGE II SPEARS PACK OF 5
FDA UDI
KATENA PRODUCTS, INC.·00841668112199·
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506073809·MCLUCAS TRIPLE FUNCTION SUCTION / IRRIGATION LO...
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016289·
Cranial Electrotherapy Stimulator To Treat Depression
FDA Pre-Market Approval
FDA Class 3
·ProlivRx System
WU'S POWERED WHEELCHAIR, MAMBO 36X
FDA 510(k)
FDA Class 2
·Physical Medicine
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025
GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·October 18, 2023
GMK HINGE AND REVISION TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2025
GMK HINGE AND REVISION TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025
GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·March 22, 2024
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 14, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 15, 2011
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·July 26, 2013
GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 21, 2023
GMK HINGE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·March 11, 2025