9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CHOP SPINE FRAME
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Celerity HP Chemical Indicator (CI)
FDA 510(k)
FDA Class 2
·General Hospital
SERIM DISINTEK GTA 2.1%, MODEL: 5164
FDA 510(k)
FDA Class 2
·General Hospital
SINGLE USE 3-LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDR·February 20, 2014
POLYROX PX 53/15-BP
FDA Adverse Event
Other
·BIOTRONIK SE & CO. KG·Product code NVZ·October 22, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 21, 2012
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015