11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMSURE URETHRAL CATHETERIZATION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820307120·SCISSORS, SURGICAL TISSUE, DENTAL
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837050979·
MODIFICATION TO MALE TO MALE LUER ADAPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTABLE INTENSIVE CARE UNIT, MODEL PIC
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 5, 2024
CORDLESS DRIVER 2 HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·April 2, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 22, 2011
ATLAS II VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·August 22, 2014
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·December 24, 2014
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