16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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