11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EPI-SCAN, MODEL P 100
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032935·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm B...
SYNTHES 1.5MM TI BROW LIFT SCREW
FDA 510(k)
FDA Class 2
·Dental
THECURVE, ITEM 507
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
NKS PM-L
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 3, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 29, 2011
CANNULATED POLY SCREWDRIVER II-MOD
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code HXX·April 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
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