13 results
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23ms
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Sources: EU EUDAMED, US FDA
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