10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
FDA 510(k)
FDA Class 2
·Orthopedic
SOFTIQUE, MODEL GI 11001
FDA 510(k)
FDA Class 2
·Physical Medicine
CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 7, 2012
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·April 15, 2015
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 6, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014
ASR XL ACETABULAR SYSTEM
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·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