14 results · 40ms · Sources: EU EUDAMED, US FDA

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SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS

FDA 510(k)
FDA Class 2 ·Orthopedic

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809846379·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE-...

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020

REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

ACRYSOF TORIC

FDA Adverse Event
Malfunction ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·May 23, 2008

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011

30 ML BD LUER-LOK TIP SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 15, 2020

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·December 29, 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

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024