14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
FDA 510(k)
FDA Class 2
·Orthopedic
6PW - CPRotector® ONE Deluxe - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113776·AIR INJECT CANNULA 27GA
24M - Salt River Project-21 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal
Secure Wear USA Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 7, 2016
VOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 10, 2008
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013
PULSE GENERATOR, PERMANENT, IMPLANTABLE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NVZ·September 6, 2017
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
FDA Enforcement
Class II
·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023