11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICRO TARGETING ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033173·Baltic Denture System BDLoad BDLoad ↓ Mw6 PLSEu...
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASPIRE COVERED STENT AND DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 27, 2023
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 1, 2013
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·February 28, 2011
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code FMK·April 23, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016