15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RHYTHMIA MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INTELLAMAP ORION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016
GYRUS ACMI
FDA UDI
Gyrus ACMI, LLC·00821925033351·BILLEAU WAX CURETTE SMALL, DISPOSABLE (6/PK)
LINK Instruments - Forceps and clamps
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575033720·Orthopaedic prosthesis instrument, reusable - G...
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488464077·STERILE ULTRASOUND BIOPSY PACK
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045933·PrimaLIF LLIF PEEK Implant, 7mm X 22mm X 50mm, ...
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68120101307500·7.5mm Cannulated Bone Tap
NUVASIVE TRAVERSE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·May 23, 2022
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 24, 2013
QUADRA ASSURA DR CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 440 mm, Item Number: 814509440
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
FDA Enforcement
Class II
·Ongoing·AtriCure, Inc.·February 7, 2024