10 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
FDA 510(k)
FDA Class 2
·Neurology
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
OPUS 20, MODEL 1ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
OLYMPUS CYSTOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAJ·April 5, 2013
REALIZE ADJ GASTRIC BAND
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·April 29, 2011
INSYNC II MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·July 10, 2008
SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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