| Telemetry Monitor (iT30, iT50) (K251508) | Edan Instruments, Inc. | 2026-08-06 |
| SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (K252463) | Edan Instruments, Inc. | 2026-07-02 |
| Holter ECG and ABP system (HolterABP) (K251591) | Edan Instruments, Inc. | 2026-02-09 |
| Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (K251268) | Edan Instruments, Inc. | 2025-12-23 |
| Fetal & Maternal Monitor (F15A, F15A Air) (K241882) | Edan Instruments, Inc. | 2025-08-27 |
| Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (K250179) | Edan Instruments, Inc. | 2025-07-29 |
| 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) (K250214) | Edan Instruments, Inc. | 2025-02-20 |
| Patient Monitor (RespArray) (K240320) | Edan Instruments, Inc. | 2024-06-28 |
| Stimulation System (PA series, PR series, S series and Q series) (K232786) | Edan Instruments, Inc. | 2024-05-16 |
| Patient Monitor (iX10, iX12, iX15) (K232962) | Edan Instruments, Inc. | 2024-04-19 |
| Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (K233038) | Edan Instruments, Inc. | 2024-03-08 |
| Central Monitoring System (MFM-CMS) (K232694) | Edan Instruments, Inc. | 2024-02-05 |
| Holter ECG and ABP System (K230184) | Edan Instruments, Inc. | 2023-09-25 |
| Electrocardiograph: SE-1200 Pro and SE-1201 Pro (K222902) | Edan Instruments, Inc. | 2023-07-28 |
| Patient Monitor: RespArray (K220308) | Edan Instruments, Inc. | 2022-08-11 |
| Electrocardiograph (K212278) | Edan Instruments, Inc. | 2022-04-07 |
| Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (K210139) | Edan Instruments, Inc. | 2021-10-01 |
| electrocardiograph: SE-1202 (K210140) | Edan Instruments, Inc. | 2021-10-01 |
| Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (K202892) | Edan Instruments, Inc. | 2021-01-28 |
| 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 (K202856) | Edan Instruments, Inc. | 2021-01-25 |
| Patient Monitor (K202336) | Edan Instruments, Inc. | 2021-01-23 |
| Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System (K192879) | Edan Instruments, Inc. | 2020-05-21 |
| Patient Monitor (K192514) | Edan Instruments, Inc. | 2020-04-02 |
| Diagnostic Ultrasound System (K192791) | Edan Instruments, Inc. | 2019-11-27 |
| Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System (K190186) | Edan Instruments, Inc. | 2019-03-28 |
| vital signs monitor (K180380) | Edan Instruments, Inc. | 2018-12-21 |
| Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (K173042) | Edan Instruments, Inc. | 2018-08-30 |
| SD1 Ultrasonic Pocket Doppler (K172780) | Edan Instruments, Inc. | 2018-06-06 |
| Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System (K180862) | Edan Instruments, Inc. | 2018-05-24 |
| U60 Diagnostic Ultrasound System (K180408) | Edan Instruments, Inc. | 2018-04-13 |
| Electrocardiograph (K171942) | Edan Instruments, Inc. | 2018-01-24 |
| U50 Diagnostic Ultrasound System (K173003) | Edan Instruments, Inc. | 2017-11-15 |
| U2 Diagnostic Ultrasound System (K172380) | Edan Instruments, Inc. | 2017-09-29 |
| Electrocardiograph (K171943) | Edan Instruments, Inc. | 2017-09-25 |
| Central Monitoring System (K171178) | Edan Instruments, Inc. | 2017-09-06 |
| Acclarix AX4 Diagnostic Ultrasound System (K171900) | Edan Instruments, Inc. | 2017-08-18 |
| Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System (K171824) | Edan Instruments, Inc. | 2017-07-18 |
| Electrocardiograph (K170995) | Edan Instruments, Inc. | 2017-06-02 |
| PC ECG (K160876) | Edan Instruments, Inc. | 2017-02-15 |
| Telemetry Transmitter (K161056) | Edan Instruments, Inc. | 2017-02-03 |
| Acclarix LX8 Diagnostic Ultrasound System (K162055) | Edan Instruments, Inc. | 2017-01-31 |
| Patient Monitor (K160981) | Edan Instruments, Inc. | 2016-12-22 |
| EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control (K151978) | Edan Instruments, Inc. | 2016-07-15 |
| PC ECG (K161302) | Edan Instruments, Inc. | 2016-07-01 |
| Acclarix AX8 Diagnostic Ultrasound System (K161300) | Edan Instruments, Inc. | 2016-05-31 |
| Patient Monitor (K152552) | Edan Instruments, Inc. | 2016-04-29 |
| Acclarix LX8 Diagnostic Ultrasound System (K160790) | Edan Instruments, Inc. | 2016-04-04 |
| PC ECG (K152427) | Edan Instruments, Inc. | 2016-02-05 |
| SD5 & SD6 Ultrasonic Tabletop Doppler (K153475) | Edan Instruments, Inc. | 2016-01-29 |
| Holter System (K151787) | Edan Instruments, Inc. | 2016-01-27 |
| Video Colposcope (K151878) | Edan Instruments, Inc. | 2015-12-01 |
| Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express (K150901) | Edan Instruments, Inc. | 2015-07-01 |
| Acclarix Diagnostic Ultrasound System (K150999) | Edan Instruments, Inc. | 2015-05-06 |
| CENTRAL MONITORING SYSTEM (K143695) | Edan Instruments, Inc. | 2015-03-30 |
| U50 Diagnostic Ultrasound System (K142511) | Edan Instruments, Inc. | 2015-02-20 |
| ULTRASONIC POCKET DOPPLER (K140579) | Edan Instruments, Inc. | 2015-02-06 |
| IM60/IM70 PATIENT MONITOR (K131971) | Edan Instruments, Inc. | 2014-03-20 |
| SE-601 SERIES ELECTROCARDIOGRAPH (K131503) | Edan Instruments, Inc. | 2014-02-25 |
| PC ECG (K131819) | Edan Instruments, Inc. | 2013-11-22 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K131830) | Edan Instruments, Inc. | 2013-09-17 |
| VITAL SIGNS MONITOR (K131818) | Edan Instruments, Inc. | 2013-08-30 |
| MFM-CMS CENTRAL MONITORING SYSTEM (K120727) | Edan Instruments, Inc. | 2013-06-21 |
| DIAGNOSTIC ULTRASOUND SYSTEM (K123249) | Edan Instruments, Inc. | 2013-02-08 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 (K122574) | Edan Instruments, Inc. | 2012-10-12 |
| PATIENT MONITOR (K120173) | Edan Instruments, Inc. | 2012-05-16 |
| ELECTROCARDIOGRAPH (K120188) | Edan Instruments, Inc. | 2012-03-16 |
| VITAL SIGNS MONITOR (K120144) | Edan Instruments, Inc. | 2012-02-14 |
| PATIENT MONITOR (K113653) | Edan Instruments, Inc. | 2012-02-06 |
| PATIENT MONITOR (K113623) | Edan Instruments, Inc. | 2012-02-01 |
| PATIENT MONITOR (K110922) | Edan Instruments, Inc. | 2011-07-20 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K110999) | Edan Instruments, Inc. | 2011-04-26 |
| FETAL MONITORS, MODELS F2 AND F3 (K102140) | Edan Instruments, Inc. | 2011-01-13 |
| CENTRAL MONITORING SYSTEM (K100358) | Edan Instruments, Inc. | 2011-01-06 |
| VITAL SIGNS MONITOR (K102835) | Edan Instruments, Inc. | 2010-12-27 |
| PC ECG (K102854) | Edan Instruments, Inc. | 2010-12-03 |
| ELECTROCARDIOGRAPH (K102830) | Edan Instruments, Inc. | 2010-12-02 |
| VITAL SIGNS MONITOR MODEL M3B (K101539) | Edan Instruments, Inc. | 2010-11-24 |
| FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS (K100797) | Edan Instruments, Inc. | 2010-11-10 |
| ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (K102138) | Edan Instruments, Inc. | 2010-10-28 |
| SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (K101960) | Edan Instruments, Inc. | 2010-08-10 |
| SE-601 SERIES ELECTROCARDIOGRAPH (K093869) | Edan Instruments, Inc. | 2010-04-01 |
| H100B PULSE OXIMETER (K092727) | Edan Instruments, Inc. | 2009-12-03 |
| ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 (K092997) | Edan Instruments, Inc. | 2009-11-10 |
| PC ECG, MODEL SE-1010 (K092010) | Edan Instruments, Inc. | 2009-10-22 |
| SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 (K091513) | Edan Instruments, Inc. | 2009-07-24 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K091680) | Edan Instruments, Inc. | 2009-06-19 |
| SE-601 SERIES ELECTROCARDIOGRAPH (K090367) | Edan Instruments, Inc. | 2009-06-03 |
| VITAL SIGNS MONITOR (K083821) | Edan Instruments, Inc. | 2009-05-14 |
| FETAL & MATERNAL MONITOR, MODEL F6, F9 (K082602) | Edan Instruments, Inc. | 2008-11-26 |
| CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR (K082369) | Edan Instruments, Inc. | 2008-11-07 |
| SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR (K080087) | Edan Instruments, Inc. | 2008-03-11 |
| CADENCE II (K073221) | Edan Instruments, Inc. | 2007-12-28 |
| CADENCE, MODELS 2001 AND 2002 (K040903) | Edan Instruments, Inc. | 2004-09-02 |
| SONOTRAX ULTRASONIC POCKET DOPPLER (K040480) | Edan Instruments, Inc. | 2004-05-25 |