24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517573834·CoRoent Ant TLIF Ti, 10x13x40mm 0°
Cutter
FDA UDI
ADLER ORTHO SPA·08052693623815·PANTHEON CUTTER FOR TIBIAL KEEL
FlexStep
FDA UDI
Liftup A/S·05714420034006·FlexStep V2, 900, 4+1 step, indoor
OPTIVISOR BINOCULAR MAGNIFIER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896053137·OPTIVISOR BINOCULAR MAGNIFIER #DA-5
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702498714·Elvarex 2/Knee High/Slant-Closed Toe/Dotted 2,5...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702275667·Elvarex 3/Thigh High/Profile, Slant, Open Toe, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197397957·Rainer Cervical Microdiscectomy Curette,
backwa...
CRP HS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SYNERGY FLOW
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 3, 2024
ROCCIA
FDA UDI
Silony Medical GmbH·04054896028743·ROCCIA MultiLIF Cage 10x34 mm, 0° Lor.
8110 ALARIS SYRINGE PUMP
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 7, 2021
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 19, 2014
8110 ALARIS SYRINGE PUMP
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 8, 2021
ESTECH REMOTE ACCESS PERFUSION CANNULA NB21FR
FDA Adverse Event
Malfunction
·ESTECH·Product code DWF·October 19, 2007
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
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