25 results · 24ms · Sources: EU EUDAMED, US FDA

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GBrain MRI

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2025

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813057780·STERILE CARBIDE BUR RA 1/2

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165675·Integra® Jarit® Nylon Cap, for REF# 250-415, Pa...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154997634·Bone Screws w. increased head,Cross Pin

Meridian

FDA UDI
Seaspine Orthopedics Corporation·10889981310387·No-Profile Interbody, 4-Hole Faceplate 16mm

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011250416200·ceraMotion® PZr Press Liner D4, 20 g / dental c...

ProCinch Adjustable Loop Device

FDA 510(k)
FDA Class 2 ·Orthopedic

OSSAPLAST ORTHO

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
aap Implantate AG·04042409445101·Cannulated Headless Bone Screw 2.5, L 16, TL 4 ...

SKINTACT

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code MKJ·January 13, 2026

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 3, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

36MM COCR MODULAR HEAD STD

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 26, 2013

Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

NavaClick Syringe and Needle, Model Number LIN02

FDA Enforcement
Class III ·Ongoing·LINEAGE BIOMEDICAL, INC·August 14, 2024

Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

FDA Enforcement
Class II ·Ongoing·Diagnostica Stago, Inc.·March 25, 2026