10 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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INFANT APNEA MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580271000001·SURE-SNAP 2. MOLAR UPR LFT SZ 10
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
FDA 510(k)
FDA Class 2
·Orthopedic
INFINION? PRO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 12, 2026
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2014
AMBIENT SUPER TURBOVAC
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATE·Product code GEI·September 12, 2012
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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