9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIRVO SERIES HUMIDIFIERS
FDA 510(k)
FDA Class 2
·Anesthesiology
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ZIPPY, MODEL I88WA
FDA 510(k)
FDA Class 2
·Physical Medicine
SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 24, 2021
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 3, 2013
QUATTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 11, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 31, 2008
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
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