5 results · 11ms · Sources: EU EUDAMED, US FDA

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VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code FTM·December 11, 2020

Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·December 26, 2012

Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

FDA Recall
Terminated ·Tournier, Inc.·Product code KWS·October 20, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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