10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
BARRETT UNICONDYLAR TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 22, 2013
TRUE TRACK SMART SYSTEM
FDA Adverse Event
Malfunction
·HOME DIAGNOSTICS, INC.·Product code NBW·July 2, 2008
ARTICULEZE BALL 28 +5 BR
FDA Adverse Event
Injury
·DEPUY SUZHOU·Product code JDI·April 15, 2011
BD PHOENIX NID
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·March 27, 2021
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024