13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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R&D CBC-3D + CRP HEMATOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7603061511·15mm x 110mm Portal Tube
O-LAS OPHTHALMIC PHOTODISRUPTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYTOFLEX MESH
FDA 510(k)
FDA Class 2
·Dental
145-DEG PE 40MM HUM LINER +2.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 12, 2024
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 27, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·March 16, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·June 17, 2008
DYNESYS LIS, STABILIZING CORD, 200
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code NQP·May 2, 2019
REVIVE - THROMBECTOMY DEVICE
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code DXE·January 29, 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
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018