23 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Klassic Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113216345·Intent to be used with suture material for tiss...
TACIT
FDA UDI
DEPUY MITEK, LLC·10886705001767·TACIT Drill With Stop-Hand 1.7mm
Nex-Link®
FDA UDI
ZIMMER SPINE, INC.·00889024332430·
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383514736·"An absorbent paper points is an endodontic pap...
TLC Uni Knee Femoral Implant
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077266·
Grappler Suture Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
AortaSTAT Occlusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
SUCTION CANISTER
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KDQ·April 7, 2023
SUCTION CANISTERS
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KDQ·April 6, 2023
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 29, 2025
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
FDA Enforcement
Class II
·Terminated·HemoCue AB·September 18, 2013
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024