14 results · 20ms · Sources: EU EUDAMED, US FDA

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DESARA MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PINNACLE®

FDA UDI
B. BRAUN MEDICAL INC.·04046955772315·SCB 250ML EVA MIXING CONT. SINGLE PACK

1230 1Way Valve

FDA UDI
HANS RUDOLPH, INC.·00874750009152·1230B 1WAY 15MMOD/10.5MMID PTS

InFill Lordotic TLIF

FDA UDI
PINNACLE SPINE GROUP, LLC·00814729025042·

CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25

FDA 510(k)
FDA Class 2 ·Cardiovascular

KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 24, 2018

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·September 9, 2022

VERCISE GENUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 8, 2024

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

DUROM US ACETABULAR COMPONENT 54/48 N

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWA·September 10, 2014

UNKNOWN DEPUY ACETABULAR LINER

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 19, 2011

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025