10 results · 20ms · Sources: EU EUDAMED, US FDA

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TRU FLU, MODEL 751230

FDA 510(k)
FDA Class 2 ·Microbiology

DS DS I-SERIES

FDA 510(k)
FDA Class 2 ·Radiology

GSIBP BLOOD PRESSURE CUFF

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2026

INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS-SELZACH·Product code HTY·May 3, 2013

CER BIOLOXD OPTION HD 36MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·September 16, 2014

SCREWS & WASHERS, 14MM

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MBI·May 3, 2011

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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