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

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SMITH & NEPHEW CIRCULAR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AMBULATORY ENTERAL NUTRITION PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

FDA Adverse Event
Malfunction ·AESCULAP, INC.·Product code GEI·April 15, 2015

PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

FDA Adverse Event
Injury ·ELLIPSE TECHNOLOGIES, INCORPORATED·Product code HSB·May 3, 2013

CLEAR CARE

FDA Adverse Event
Injury ·CIBA VISION CORP·Product code LPN·September 10, 2014

ARCHITECT TOTAL B-HCG REAGENT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code DHA·May 18, 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

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021