8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OB-GYN CONTROL SERA (CODE 196300)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NGAGE
FDA UDI
Orthofix US LLC·18257200073740·NGAGE 6-LOBE 13X17MM MESH, 9MM
LIMB HOLDER, TECNOL REMINDER
FDA 510(k)EMBRYOASSIST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SECURESTRAP
FDA Adverse Event
Injury
·ETHICON INC.·Product code GDW·April 21, 2014
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·September 26, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 9, 2015
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-024-35-2509, l) 02-024-35-2510, m) 02-024-35-2511, n) 02-024-35-2512, o) 02-024-35-3010, p) 02-024-35-3011, q) 02-024-35-3012, r) 02-024-35-3013, s) 02-024-35-3513, t) 02-024-35-3515, u) 02-024-35-4012, v) 02-024-35-4013, w) 02-024-35-4510, x) 02-024-35-4515, y) 02-024-35-5011, z) 02-024-35-5012, aa) 02-024-44-1511, bb) 02-024-44-2009, cc) 02-024-44-2011, dd) 02-024-44-2015, ee) 02-024-44-2510, ff) 02-024-44-2515, gg) 02-024-44-3009, hh) 02-024-44-3011, ii) 02-024-44-3013, jj) 02-024-44-3015, kk) 02-024-44-3509, ll) 02-024-44-4009, mm) 02-024-44-4509, nn) 02-024-44-4511, oo) 02-024-44-4512, pp) 02-024-44-4513, qq) 02-024-44-5013
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·December 27, 2023