10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
C.T.M. POWER CHAIR, MODEL HS-1500
FDA 510(k)
FDA Class 2
·Physical Medicine
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RESURFACING
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 22, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·January 31, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
FDA Recall
Terminated
·Fujinon Inc·Product code FDS·July 31, 2013
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·August 31, 2015
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·July 21, 2017
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024