17 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
FDA 510(k)
FDA Class 2
·Cardiovascular
NV MICROCATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020
ADVIA 1650 CHOLINESTERASE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
MANIFOLD IN K09-03750 CONVENIENCE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·April 30, 2009
HIGH PRESSURE TUBING /K09-03750 CONVENIENCE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code FPK·April 30, 2009
SYNVISC ONE (HYLAN G-F 20) INJECTION
FDA Adverse Event
Injury
·GENZYME SURGERY·Product code MOZ·April 29, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
UNKNOWN DEPUY DURALOC LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 12, 2011
IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)
FDA Adverse Event
Malfunction
·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNY·May 14, 2026
IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)
FDA Adverse Event
Malfunction
·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNY·May 13, 2026
IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)
FDA Adverse Event
Malfunction
·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNY·May 13, 2026
IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)
FDA Adverse Event
Malfunction
·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNY·May 14, 2026
IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)
FDA Adverse Event
Malfunction
·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNY·May 13, 2026
IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)
FDA Adverse Event
Malfunction
·BEAVER-VISITEC INTERNATIONAL, INC.·Product code HNY·May 13, 2026
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