12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUTTER ELECTROSURGICAL CABLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOTTA AMBULATORY RECORDER
FDA 510(k)
FDA Class 2
·Neurology
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·April 23, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 1, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
ORTHOPEDIC SALVAGE SYSTEM BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 28, 2017
ORTHOPEDIC SALVAGE SYSTEM YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·November 28, 2017
ORTHOPEDIC SALVAGE SYSTEM AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 28, 2017
ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 28, 2017
ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 28, 2017
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