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

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Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NeoFuse Ti3D PLIF/TLIF

FDA UDI
XENIX MEDICAL LLC·00818345021129·Ti3D CAGE 24L x 10W x 8H

NeoFuse HA Enhanced PLIF/TLIF

FDA UDI
XENIX MEDICAL LLC·00818345020160·HA CAGE 24L x 10W x 8H

N/A

FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369849·I.V. POST WITH CLAMP

Tyber Medical

FDA UDI
Tyber Medical, LLC·M695502P241008S1·PLIF 24mm x 8mm x 10mm x 0 °, TyPEEK, Sterile

Tyber Medical

FDA UDI
Tyber Medical, LLC·M695302P241008S1·PLIF 24mm x 8mm x 10mm x 0 °, PEEK, Sterile

EYE-CEPT REWETTING DROPS

FDA 510(k)
FDA Class 2 ·Ophthalmic

Bose SoundControl Hearing Aids

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

M/DN®

FDA UDI
Zimmer, Inc.·00889024041271·

M/DN®

FDA UDI
Zimmer, Inc.·00889024041264·

EASYPOINT NEEDLE

FDA Adverse Event
Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

EASYPOINT NEEDLE

FDA Adverse Event
Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·November 21, 2008

COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·January 18, 2011

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·September 12, 2024

BD CONVENTIONAL NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 2, 2025

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020