11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MP-1 MICROPERIMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
OCCU-FLO PUNCTUM PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
FDA 510(k)
FDA Class 2
·Physical Medicine
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
GPS PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·June 13, 2008
UNICEL DXI WASH BUFFER II
FDA Adverse Event
BECKMAN COULTER INC.·Product code LDT·April 19, 2011
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
PVA FOAM EMBOLIZATION PARTICLES
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 26, 2018
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015