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