10 results · 27ms · Sources: EU EUDAMED, US FDA

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CO2 CALIBRATOR/DILUENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033643·Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEu...

AUSAM TOTAL ALBUMIN ASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NUMED Z-MED PTV CATHERERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

COATED VICRYL (POLYGLACTIN 910) SUTURE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAM·April 3, 2013

MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·February 11, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

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