12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
FDA 510(k)
FDA Class 2
·Cardiovascular
TREATVISION
FDA 510(k)
FDA Class 2
·Radiology
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
FDA 510(k)
FDA Class 2
·Cardiovascular
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
VELA
FDA Adverse Event
CAREFUSION 211, INC.·Product code CBK·April 2, 2013
UNKNOWN PAINPUMP PRODUCT
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS KALAMAZOO·Product code MEB·March 28, 2011
VENTAK MINI IV
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 30, 2011
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 2011
PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
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