17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756974363·ANGIOGRAPHIC TRAY
Bone Screws
FDA UDI
ORTHOFIX SRL·18033509850080·CORTICAL SCREW 80/30 MM STERILE SHAFT D 6MM THR...
8 Degree Lordotic, Opticage Expandable Interbody Implant
FDA UDI
INTERVENTIONAL SPINE, INC·00811954013318·11mm Width x 30mm Length by 11mm-16mm Footprint...
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981079567·In-Situ Rod Bender, Right
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm
Maxtown Medical
FDA UDI
Modern Surgical Instruments LLC·B419349101080·
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm
USS-LINE EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
MODALIXX
FDA 510(k)
FDA Class 2
·Radiology
CHEMO AID ADD-A-LINE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·November 30, 2010
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·July 2, 2014
BD PHASEAL PROTECTOR P14
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·June 4, 2020
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 23, 2022
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024