16 results · 23ms · Sources: EU EUDAMED, US FDA

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DIMISIL SCAR GEL

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

HEMADERM COTAINING HEMADEX CLOTTING BEADS

FDA 510(k)
FDA Unclassified ·Unknown

VICTORCH MEDITEK'S HCG TEST CARD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INNOVA 4100

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

INNOVA 4100

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

FDA Adverse Event
Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

COMPREHENSIVE REVERSE SHOULDER HEAD STANDARD 41MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWS·March 27, 2013

ACRYSOF IQ TORIC

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 3, 2011

ABL800 FLEX WITH FLEXQ MODULE

FDA Adverse Event
Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·April 1, 2008

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code DZI·October 6, 2020

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code DZI·July 15, 2025

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code ELC·September 9, 2016

Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018