18 results
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19ms
·
Sources: EU EUDAMED, US FDA
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
FDA 510(k)
FDA Class 2
·Cardiovascular
GIBSON HEALTHCARE
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975012548·Gibson Healthcare Synthetic Putty, Mineral-Coll...
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376654355·Offset Spinous Process Clamp, X Large
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776081539·Claw Forcep
TASTES GREAT
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730004406·Alginate Flavoring Blueberry 2 fl oz per bottle
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251103200·ceraMotion® Ti Base Dentin Modifier ochre, 20 g...
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
FDA 510(k)
FDA Class 2
·Ophthalmic
ASAHI Corsair Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
LOQTEQ®
FDA UDI
aap Implantate AG·04042409363092·LOQTEQ® VA Volar Distal Radius Plate 2.5, narro...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
MERIT HEMOSTASIS VALVE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQX·August 25, 2011
CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JIX·December 5, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 8, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019