9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BODAI M.D.D. ADAPTOR(TM)
FDA 510(k)
FDA Class 1
·Anesthesiology
Surgistar
FDA UDI
SURGISTAR, INC.·00878799003355·
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
iStim S2 OTC Pain Relief TENS
FDA 510(k)
FDA Class 2
·Neurology
PRECISION SPECTRA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2014
CVC KIT: 3-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·October 8, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 20, 2012
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024