11 results
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19ms
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Sources: EU EUDAMED, US FDA
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042440·IMBRULIA 70, SIZE ML, MOKA, GRADUATED COMPRESSI...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867015·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND CLOSED...
F-11 FOLDING POWER CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO CLEARFIL LINER BOND 2V
FDA 510(k)
FDA Class 2
·Dental
OCULIGHT GL LASER
FDA Adverse Event
Malfunction
·IRIDEX CORP.·Product code GEX·January 11, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 6, 2011
VITALITY 2 VR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 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