10 results · 21ms · Sources: EU EUDAMED, US FDA

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DENSICHECK PLUS

FDA 510(k)
FDA Class 2 ·Microbiology

CONMED

FDA UDI
Conmed Corporation·10845854000793·ROUND BUR, EXTRA LONG, CARBIDE, 2MM

INFUSION CATHETER EXTENSION SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER

FDA 510(k)
FDA Class 2 ·Radiology

VERCISE GENUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·March 23, 2023

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 22, 2015

PVC, CLEAR, CONTRAST INJECTION TUBING

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·April 14, 2011

CARDIOSAVE

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·August 21, 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

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