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

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POWDER FREE VINYL PATIENT EXAMINATION GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450590843·

PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO ENVOY PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

UNK - IOL

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 30, 2013

ENSEAL G2 STRAIGHT JAW

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·September 16, 2014

BIVONA FLEXTEND SILICONE TRACHEOSTOMY TUBE

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·May 12, 2011

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

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