9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
FDA 510(k)
FDA Class 2
·Anesthesiology
Sklar
FDA UDI
SKLAR CORPORATION·10649111392559·KALLMORGEN VAG SPEC&RETR SET2
US SENSOR #CG-930P; TOCO SENSOR CG-940P
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 9, 2013
GII
FDA Adverse Event
SMITH-NEPHEW INC.·Product code JWH·November 20, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
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