10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693236560·Formal-Fixx is a variation of neutral buffered ...
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556813386·ANATOMIC INSTRUMENT TRAY
...
HANSO ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
PrisMax System Version 2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUPRAMID BLACK 4/0 (1.5) 45CM DS19
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·September 12, 2019
OMNIFIT AXIAL REAMER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·March 6, 2013
MAXIMO DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021