10 results
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19ms
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Sources: EU EUDAMED, US FDA
EMIT(R) II BARBITURATE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Integra DP Valve System
FDA UDI
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033509·Integra DP Valve System is an implantable devic...
PRAIRIE CRUISER
FDA 510(k)
FDA Class 2
·Physical Medicine
TIDI FACEMASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG TPS 5F MAX
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS INC.·Product code LJS·May 9, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 18, 2010
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·November 12, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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