11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIACAP ULTRA DIALYSIS FLUID FILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809846249·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE LARGE FU...
7F LAUNCHER GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 7, 2020
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GCJ·May 27, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 17, 2021
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