11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PERMAGUM ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
BoneCam
FDA UDI
MEDLINE INDUSTRIES, INC.·00818614021164·
Mrk, Ocular
FDA UDI
KATENA PRODUCTS, INC.·00841668119938·Harman Capsulorrhexis Marker
HSB - Cement Burn Component
FDA UDI
Certified Safety Manufacturing, Inc.·00766588121178·HSB - Cement Burn Component
Vinyl Patient Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
EXPEDIUM 5.50 POLYAXIAL SCREW 7X50, TI
FDA Adverse Event
Malfunction
·DEPUY SPINE, INC.·Product code MNH·August 17, 2010
DYNESYS CORD
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code NQP·December 11, 2017
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