Ethicon, Inc. - FDA 510(k) Cleared Devices
Recent clearances: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices, STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device, MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
204
Total
197
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ethicon, Inc. Cardiovascular ✕
9 devices
Cleared
Aug 02, 2018
Temporary Cardiac Pacing Wire
Cardiovascular
219d
Cleared
Dec 11, 2002
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
Cardiovascular
20d
Cleared
Nov 07, 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
Cardiovascular
36d
Cleared
Apr 10, 1998
TEMPORARY CARDIAC PACING WIRE
Cardiovascular
60d
Cleared
Dec 10, 1981
ETHICON* TEMP. CARDIAC PACING WIRE
Cardiovascular
34d
Cleared
Aug 31, 1981
DACRON PLEDGET SUTURE BUTTRESS
Cardiovascular
19d
Cleared
Aug 12, 1981
TEFLON PLEDGET SUTURE BUTTRESS
Cardiovascular
42d
Cleared
Dec 04, 1978
TEMPORARY CARDIAC PACING WIRE
Cardiovascular
172d
Cleared
Apr 28, 1978
AORTIC PUMP
Cardiovascular
22d