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

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DR DISPOSABLE PROPHY ANGLE MODEL H310

FDA 510(k)
FDA Class 1 ·Dental

MASIF POWDER-FREE PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

FDA 510(k)
FDA Class 2 ·General Hospital

INTRALASE FS2

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013

VISX EXCIMER LASER

FDA Adverse Event
Injury ·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010

INTRALASE FS2

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013

INTRALASE FS2

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 16, 2013

INRATIO

FDA Adverse Event
Injury ·HEMOSENSE, INC.·Product code JPA·June 11, 2008

OT ULTRA EASY METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·April 15, 2011

BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 20, 2022

BD MULTITEST¿ 6-COLOR TBNK

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024

BD MULTITEST¿ 6-COLOR TBNK

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

FDA 510(k)
FDA Class 2 ·Neurology

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018