12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NIOX MINO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Integra® Spider™ Limted Wrist Fusion System
FDA UDI
INTEGRA LIFESCIENCES CORPORATION·10381780064855·The Integra Spider Limited Wrist Fusion bone sc...
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 24, 2025
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
FDA 510(k)
FDA Unclassified
·Unknown
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 23, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 31, 2011
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015