Edan Instruments, Inc.
Edan Instruments, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026.
Top product codes for Edan Instruments, Inc.
Recent clearances by Edan Instruments, Inc.
- K251508 — Telemetry Monitor (iT30, iT50)
- K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- K251591 — Holter ECG and ABP system (HolterABP)
- K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- K241882 — Fetal & Maternal Monitor (F15A, F15A Air)
- K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
- K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
- K240320 — Patient Monitor (RespArray)
- K232786 — Stimulation System (PA series, PR series, S series and Q series)
- K232962 — Patient Monitor (iX10, iX12, iX15)
- K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
- K232694 — Central Monitoring System (MFM-CMS)
- K230184 — Holter ECG and ABP System
- K222902 — Electrocardiograph: SE-1200 Pro and SE-1201 Pro
- K220308 — Patient Monitor: RespArray
- K212278 — Electrocardiograph
- K210139 — Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
- K210140 — electrocardiograph: SE-1202
- K202892 — Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
- K202856 — Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
- K202336 — Patient Monitor
- K192879 — Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
- K192514 — Patient Monitor
- K192791 — Diagnostic Ultrasound System
- K190186 — Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
- K180380 — vital signs monitor
- K173042 — Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
- K172780 — SD1 Ultrasonic Pocket Doppler
- K180862 — Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
- K180408 — U60 Diagnostic Ultrasound System
- K171942 — Electrocardiograph
- K173003 — U50 Diagnostic Ultrasound System
- K172380 — U2 Diagnostic Ultrasound System
- K171943 — Electrocardiograph
- K171178 — Central Monitoring System
- K171900 — Acclarix AX4 Diagnostic Ultrasound System
- K171824 — Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
- K170995 — Electrocardiograph
- K160876 — PC ECG
- K161056 — Telemetry Transmitter
- K162055 — Acclarix LX8 Diagnostic Ultrasound System
- K160981 — Patient Monitor
- K151978 — EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
- K161302 — PC ECG
- K161300 — Acclarix AX8 Diagnostic Ultrasound System
- K152552 — Patient Monitor
- K160790 — Acclarix LX8 Diagnostic Ultrasound System
- K152427 — PC ECG
- K153475 — SD5 & SD6 Ultrasonic Tabletop Doppler
- K151787 — Holter System
- K151878 — Video Colposcope
- K150901 — Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
- K150999 — Acclarix Diagnostic Ultrasound System
- K143695 — CENTRAL MONITORING SYSTEM
- K142511 — U50 Diagnostic Ultrasound System
- K140579 — ULTRASONIC POCKET DOPPLER
- K131971 — IM60/IM70 PATIENT MONITOR
- K131503 — SE-601 SERIES ELECTROCARDIOGRAPH
- K131819 — PC ECG
- K131830 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K131818 — VITAL SIGNS MONITOR
- K120727 — MFM-CMS CENTRAL MONITORING SYSTEM
- K123249 — DIAGNOSTIC ULTRASOUND SYSTEM
- K122574 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
- K120173 — PATIENT MONITOR
- K120188 — ELECTROCARDIOGRAPH
- K120144 — VITAL SIGNS MONITOR
- K113653 — PATIENT MONITOR
- K113623 — PATIENT MONITOR
- K110922 — PATIENT MONITOR
- K110999 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K102140 — FETAL MONITORS, MODELS F2 AND F3
- K100358 — CENTRAL MONITORING SYSTEM
- K102835 — VITAL SIGNS MONITOR
- K102854 — PC ECG
- K102830 — ELECTROCARDIOGRAPH
- K101539 — VITAL SIGNS MONITOR MODEL M3B
- K100797 — FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
- K102138 — ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
- K101960 — SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
- K093869 — SE-601 SERIES ELECTROCARDIOGRAPH
- K092727 — H100B PULSE OXIMETER
- K092997 — ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
- K092010 — PC ECG, MODEL SE-1010
- K091513 — SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
- K091680 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K090367 — SE-601 SERIES ELECTROCARDIOGRAPH
- K083821 — VITAL SIGNS MONITOR
- K082602 — FETAL & MATERNAL MONITOR, MODEL F6, F9
- K082369 — CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
- K080087 — SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
- K073221 — CADENCE II
- K040903 — CADENCE, MODELS 2001 AND 2002
- K040480 — SONOTRAX ULTRASONIC POCKET DOPPLER
Data sourced from openFDA. This site is unofficial and independent of the FDA.