10 results · 26ms · Sources: EU EUDAMED, US FDA

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AUTOMATED PULMONARY FUNCTION LABORATORY

FDA 510(k)
FDA Class 2 ·Anesthesiology

Cochlear™ Baha® Fitting Software

FDA UDI
Cochlear Bone Anchored Solutions AB·09321502036030·Program Baha Sound Processors

VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

FDA 510(k)
FDA Class 2 ·Cardiovascular

16CH AI BREAST COILS 1.5 T AND 3 T

FDA 510(k)
FDA Class 2 ·Radiology

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 9, 2014

UNKNOWN DEPUY FEMORAL STEM

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code JDI·October 24, 2012

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 27, 2007

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

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024