18 results · 31ms · Sources: EU EUDAMED, 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