9 results · 28ms · Sources: EU EUDAMED, US FDA

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NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER

FDA 510(k)
FDA Class 2 ·Orthopedic

INTUITIVE SURGICAL BIPOLAR FORCEPS

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

MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 29, 2013

NAVIGATOR 11MM X 31MM X 0DEG. SPACER

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code MAX·April 29, 2011

ASCENSIA BREEZE2 TEST STRIPS (50)

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·July 24, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 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