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

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SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION

FDA 510(k)
FDA Class 2 ·Orthopedic

Mizzy Consistency

FDA UDI
Keystone Industries·H66860817001·VPS Light Body, Reg Set

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702367508·Elvarex 3/Knee High/Closed Toe-Elephantiasis-Ve...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702247428·E2/AG/SL-OT-E/NOP2,5-T-TC/BL

MODULITH SLK LITHOTRIPTER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

XPLAN 2.1

FDA 510(k)
FDA Class 2 ·Radiology

RESERVOIR 1.8ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 29, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 13, 2011

CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code KRH·July 22, 2008

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