Edan Instruments, Inc. - FDA 510(k) Cleared Devices
92
Total
92
Cleared
0
Denied
92 devices
Cleared
Jun 06, 2018
SD1 Ultrasonic Pocket Doppler
Obstetrics & Gynecology
265d
Cleared
May 24, 2018
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound...
Radiology
52d
Cleared
Apr 13, 2018
U60 Diagnostic Ultrasound System
Radiology
58d
Cleared
Jan 24, 2018
Electrocardiograph
Cardiovascular
210d
Cleared
Nov 15, 2017
U50 Diagnostic Ultrasound System
Radiology
49d
Cleared
Sep 29, 2017
U2 Diagnostic Ultrasound System
Radiology
53d
Cleared
Sep 25, 2017
Electrocardiograph
Cardiovascular
89d
Cleared
Sep 06, 2017
Central Monitoring System
Obstetrics & Gynecology
138d
Cleared
Aug 18, 2017
Acclarix AX4 Diagnostic Ultrasound System
Radiology
53d
Cleared
Jul 18, 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound...
Radiology
29d
Cleared
Jun 02, 2017
Electrocardiograph
Cardiovascular
60d
Cleared
Feb 15, 2017
PC ECG
Cardiovascular
322d
Cleared
Feb 03, 2017
Telemetry Transmitter
Cardiovascular
295d
Cleared
Jan 31, 2017
Acclarix LX8 Diagnostic Ultrasound System
Radiology
190d
Cleared
Dec 22, 2016
Patient Monitor
Cardiovascular
259d
Cleared
Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid...
Chemistry
364d
Cleared
Jul 01, 2016
PC ECG
Cardiovascular
53d
Cleared
May 31, 2016
Acclarix AX8 Diagnostic Ultrasound System
Radiology
22d
Cleared
Apr 29, 2016
Patient Monitor
Cardiovascular
234d
Cleared
Apr 04, 2016
Acclarix LX8 Diagnostic Ultrasound System
Radiology
13d
Cleared
Feb 05, 2016
PC ECG
Cardiovascular
163d
Cleared
Jan 29, 2016
SD5 & SD6 Ultrasonic Tabletop Doppler
Radiology
58d
Cleared
Jan 27, 2016
Holter System
Cardiovascular
210d
Cleared
Dec 01, 2015
Video Colposcope
Obstetrics & Gynecology
145d
Cleared
Jul 01, 2015
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
Obstetrics & Gynecology
89d
Looking for a specific device from Edan Instruments, Inc.? Search by device name or K-number.
Search all Edan Instruments, Inc. devices