11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
FDA 510(k)
FDA Class 2
·Orthopedic
AUTODIMER ASSAY MODEL # 1431
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 5, 2025
MOSAIC
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
STONETOME STONE REMOVAL DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FDI·May 23, 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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026