9 results · 19ms · Sources: EU EUDAMED, US FDA

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MODEL 2500 PNEUMATIC PERCUSSOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODIFICATION TO CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PECTUS STRUT

FDA 510(k)
FDA Class 2 ·Orthopedic

COREVALVE 31MM AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 9, 2014

SPARC SLING SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 19, 2012

QUICKSET ACE GRATER HEAD 66MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·May 28, 2015

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 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