10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
APO-TEK LP(A)
FDA 510(k)
FDA Class 2
·Immunology
artegral
FDA UDI
Merz Dental GmbH·D7091970302·anteriors; shade C2; mould BIS
CUTTER, P606 BONE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
YELLOW LASER PHOTOCOAGULATOR YLC-500
FDA 510(k)
FDA Class 2
·Ophthalmic
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 20, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 14, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014
SPLINE HA CYLINDER 4.0 10 MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 1, 2024
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019
Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ--·April 26, 2004