13 results · 23ms · Sources: EU EUDAMED, US FDA

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FIXIT HEADREST CLAMP SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

INSTRUMENT

FDA UDI
Howmedica Osteonics Corp.·07613327181500·SC BONE DRILL

FLOWGUARD DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

GENERAL SURGICAL LAPAROSCOPES

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

CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS

FDA Adverse Event
Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·January 30, 2026

CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS

FDA Adverse Event
Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·January 22, 2026

OT VERIO IQ METER

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

QUICKFLEX MICRO LV LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 10, 2011

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIK SOFAMORE DANEK·Product code HWM·July 25, 2008

CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL

FDA Adverse Event
Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code MJP·May 23, 2025

3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ

FDA Recall
Terminated ·Product code KKX·April 7, 2003

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