14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OralTox Oral fluid Drug Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638878·CoRoent Ant TLIF PEEK, 8x11x30mm 15°
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025608·Little Retractor, 7 3/4"
Origin Short Neck Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023881·
311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP
FDA Adverse Event
Injury
·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.·Product code FTC·December 22, 2022
MERCI RETRIEVER
FDA 510(k)
FDA Class 2
·Cardiovascular
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ANN BLUNT TIP SCREW 4X52MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·May 30, 2024
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 12, 2013
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·July 21, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 23, 2008
PROXIMAL HUMERUS, LEFT, ÿ 9X160MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·May 30, 2024
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