14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IV ADMINISTRATION SET B400 SP
FDA 510(k)
FDA Class 2
·General Hospital
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042693·MARILYN 70 SHEER, SIZE M, MOKA, GRADUATED COMPR...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867749·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
FDA 510(k)
FDA Class 1
·Dental
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2025
YELLO PORT
FDA Adverse Event
Malfunction
·CLAYTON WOOD HOUSE, SURGICAL INOVATIONS·Product code GCJ·April 3, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 6, 2011
VITALITY DS
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·June 11, 2018
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013