11 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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LSO PET/CT HIREZ 64
FDA 510(k)
FDA Class 2
·Radiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867244·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND CLOSED...
PET DOSE DRAWING SYTEM
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175004678·Dose Drawing System, PET with L-Block
COALIZA PROTEIN S-FREE
FDA 510(k)
FDA Class 2
·Hematology
SOLAR 8000M SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 9, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 6, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
BACTEC MGIT
FDA Adverse Event
Malfunction
·BD DIAGNOSTIC SYSTEMS·Product code MDB·September 6, 2013
PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM, P/N 0250282011 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