8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
CONSERVA POST SYSTEM
FDA 510(k)
FDA Class 1
·Dental
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Synapse 3D Liver and Kidney Analysis
FDA 510(k)
FDA Class 2
·Radiology
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·February 4, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Other
·DEPUY INTERNATIONAL, LTD·Product code KWA·December 1, 2010
MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·July 17, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024