12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURFIX KNEE OSTEOTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110450·LOCATOR Abutment R-Tx, Tissue Level, Regular Ne...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613115296·Guthrie Skin Hook Retractor, Sharp, 2 Prongs, S...
ORTHO SUMMIT TM SAMPLE HANDLER
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·February 8, 2000
Acapella One
FDA UDI
Choice Spine, LP·00840996152822·ACAPELLA,DISTRACTOR,SM,14X16
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
COVER, BURR HOLE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code GXR·July 1, 2016
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 10, 2011
VITALITY 2 DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
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