11 results · 19ms · Sources: EU EUDAMED, US FDA

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BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)

FDA 510(k)
FDA Class 2 ·Physical Medicine

CAAS II QVA

FDA 510(k)
FDA Class 2 ·Radiology

REPLACE TPS COATED IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

VERCISE GEVIA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·February 20, 2025

STONEBREAKER SINGLE USE PROBE

FDA Adverse Event
Malfunction ·COOK INC·Product code FFK·March 28, 2018

ARIS TRANS-OBTURATOR KIT

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code FTL·April 23, 2013

LOW PROFILE SCREW, SS, 4.0 X 40MM, CANCELLOUS

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HRS·April 29, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

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