14 results
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30ms
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Sources: EU EUDAMED, US FDA
VORTEX MP
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032754·Baltic Denture System BDLoad Sm7 PLSEbm6DFs A1 ...
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 8, 2022
EZ SET INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
MOSAIC
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025
FLEXI-SEAL FMS
FDA Adverse Event
Other
·CONVATEC·Product code KNT·June 7, 2006
NUTRILINE 2D PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·March 29, 2013
SHUNT SENSOR SYS500
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 23, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 24, 2008
FLEXI-SEAL FECAL MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·October 20, 2016
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018