17 results
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23ms
·
Sources: EU EUDAMED, US FDA
X O ODONTOSURGE 4
FDA 510(k)
FDA Class 2
·Dental
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·July 25, 2023
BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
INION OTPS BIOABSOBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·November 18, 2014
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·June 9, 2024
INION OTPS BIOABSOBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·May 14, 2015
INION OTPS BIOABSORBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·March 19, 2015
DUAL RADIUS M/S SCREWLESS CUP 50MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 27, 2013
UNK -- IOL
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 3, 2011
ARCHITECT I2000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code DHA·April 1, 2008
COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015
INION OTPS BIOABSORBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·June 5, 2015
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
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