9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
USA SERIES LAPAROSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
ENDO SMARTCAP
FDA Adverse Event
MEDIVATORS·Product code KOG·February 2, 2015
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
HF RESECTION 90 DEGREE ELECTRODE NEEDLE 24-28FR 12 DEGREES
FDA Adverse Event
Malfunction
·OLYMPUS WINTER AND IBE GMBH·Product code FAS·August 21, 2014
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 14, 2011
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