12 results · 31ms · Sources: EU EUDAMED, US FDA

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LANX FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Zavation

FDA UDI
Zavation LLC·00842166112377·Z-Link Lumbar Spacer 8deg 38mmx15

Zavation

FDA UDI
Zavation LLC·00842166177390·Z-Link Lumbar Sizer 8 deg, 38mm x 15

MEDRAD QWIK-FIT SYRINGE

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER

FDA 510(k)
FDA Class 2 ·Physical Medicine

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 10, 2011

GE OEC 9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

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