11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032498·ET40, KIT 312 NFM 75 L BE ENCHANT 40
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155978·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 230mm
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 7, 2008
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·June 20, 2013
TENAX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 4, 2011
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
FDA Enforcement
Class II
·Ongoing·Carl Zeiss Metrology Inc·February 7, 2018
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015