8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088460·Bullet Distractor, 9mm
ENDOSCOPIC RETROGRADE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AllTest Fentanyl Urine Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BLAKE DRAIN
FDA Adverse Event
Injury
·ETHICON, INC.·Product code KOG·January 29, 2013
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code KOG·December 3, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024