15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARDS O.S. MONO
FDA 510(k)
FDA Class 2
·Immunology
icotec Lumbar Cage PLIF 0° / 25 mm x 10 mm
FDA UDI
icotec AG·07640164848242·icotec Lumbar Cage PLIF 0° / 25 mm x 10 mm
ENDOCLAMP AORTIC CATHETER
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code DXC·June 23, 2006
SMARTLENS
FDA 510(k)
FDA Class 2
·Ophthalmic
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 24, 2022
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·May 30, 2017
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 7, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FNL·November 12, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
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