9 results
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19ms
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Sources: EU EUDAMED, US FDA
SUBCLAVIAN CATHETER INSERTION TRAY
FDA 510(k)
FDA Class 1
·General Hospital
SPECTRA GUIDEWIRE INTRODUCER NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
PRAIRIE CRUISER
FDA 510(k)
FDA Class 2
·Physical Medicine
PINN SECTOR HA ACET CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 9, 2014
ZMR FEMORAL STEM
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LPH·October 19, 2012
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·August 11, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019