14 results · 21ms · Sources: EU EUDAMED, 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