12 results · 21ms · Sources: EU EUDAMED, US FDA

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ACCESS TOTAL T4 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RESECTION ABLATOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LIFECARE COMPACT TENS DEVICE

FDA 510(k)
FDA Class 2 ·Neurology

M.U.S.T. POLYAXIAL PEDICLE SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MNI·October 28, 2024

ZYGOMATIC IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·June 26, 2024

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·March 27, 2013

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·March 16, 2011

AXIUM 3D DETACHABLE COIL

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code HCG·April 2, 2008

ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT

FDA Adverse Event
Death ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·September 30, 2024

BROKEN SCREW EXTRACTOR HEX COUPLING

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HWB·February 23, 2015

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