9 results · 20ms · Sources: EU EUDAMED, US FDA

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ISSYS PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SALUTE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SOMATOM P30 CT SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORP.·Product code MAF·December 21, 2006

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 9, 2013

ISYMM ASPHERIC INTRAOCULAR LENS

FDA Adverse Event
Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·February 25, 2011

VITALITY DS

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

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