7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRIMODE SP DENTAL INTRA ORAL X-RAY
FDA 510(k)
FDA Class 2
·Dental
SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4
FDA 510(k)
FDA Class 2
·Radiology
NIC BRAND PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 26, 2014
CAPTURE-R READY SCREEN IV
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·November 11, 2010
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code NEK·January 3, 2013
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024