11 results
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18ms
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Sources: EU EUDAMED, US FDA
DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295124026·Advanced Antibacterial Clear Waterproof Strong ...
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080468·TAP 902-441 ADJUSTABLE 20MM
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FENNING HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code FSA·June 30, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 18, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 20, 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