21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMPI PHOENIX
FDA 510(k)
FDA Class 2
·Physical Medicine
Trestle Luxe
FDA UDI
ALPHATEC SPINE, INC.·00844856067349·4.0mm Variable Angle, Self-Drilling Hexalobe Sc...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193112527·HA PEEK EVOS Straight, ,16mmx10mmx 22mm , BICON...
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711240161·Cortical-Cancellous Variable Angle Self-Drillin...
MALLORY HEAD HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304225190·
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831240160·Straight Thoracic Catheter, 16 French x 20 IN
POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PIONEER STERNAL ASSIST IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052515·4.0mm x 16mm Poly Screw Assm. The Atoll OCT Spi...
Tether™
FDA UDI
Seaspine Orthopedics Corporation·10889981035969·Screw - Self-Tapping - Variable - 4.0x16mm
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981056582·Screw - Self-Drilling - Variable - 4.0x16mm
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 23, 2024
PLATE - 43 MM
FDA Adverse Event
Malfunction
·THEKEN SPINE·Product code KWQ·September 9, 2010
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 15, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 27, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
BD US CATHENA 18GX1.25IN STRAIGHT BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·April 17, 2025
BD US CATHENA 18GX1.25IN STRAIGHT BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·April 17, 2025
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 8, 2015
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012