10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CAPILLARY FLOW DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
VITRO MOLAR
FDA 510(k)
FDA Class 2
·Dental
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 21, 2014
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·December 3, 2007
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·June 3, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023