12 results
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28ms
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Sources: EU EUDAMED, US FDA
NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083011529·Fixed, 4 electrode, RVB, 2-5-2mm electrode spacing
ERA ANGLE 3.25MM IMP MICRO HEAD 13X4MM, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108051·Designed for both transitional and long-term de...
SYNCHRON CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
FDA 510(k)
FDA Class 2
·Cardiovascular
STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 29, 2021
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMH
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 24, 2020
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 30, 2014
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·November 17, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 8, 2013
STEM: AMISTEM-P STD SIZE 3
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code LZO·October 30, 2019
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