21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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