18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VHS SUPRACONDYLAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Propex IQ Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
POGO SCREW INSTRUMENTATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
TITANIUM SCREW LOW PROFILE 5X40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016
TITANIUM SCREW LOW PROFILE 5X40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 6, 2013
SECURA VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·July 30, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·November 24, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·July 15, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·September 9, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·September 4, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·September 24, 2025
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·January 12, 2026
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·March 4, 2026
PCCO MONITORING KIT
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code KRB·February 19, 2026
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021