DSI
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
- Advisory panel
- Cardiovascular
- Total cleared
- 398
Adverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DSI
1–100 of 398- K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)
- K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
- K240177 — Zio AT® device (A100A1001)
- K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
- K231276 — SmartCardia 7L Platform
- K193104 — Unified Arrhythmia Diagnostic System PocketECG IV
- K192732 — BodyGuardian Remote Monitoring System
- K190574 — Patient Assistant Model PA97000
- K182532 — Liba3 System
- K181658 — MobileECG 2 BT
- K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System
- K173170 — Epicardia Anywhere
- K153473 — Braemar Telemetry Patch System
- K153477 — EMMa Electronic Monitoring Management
- K152701 — Matrix Mini ECG Monitor
- K152305 — Nihon Kohden Afib Detection Program QP-039P
- K151835 — Vital Signs Patch System
- K151269 — ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
- K152491 — MoMe Software Platform
- K152550 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
- K151188 — BodyGuardian Remote Monitoring System
- K143359 — CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
- K151681 — IntelliVue Patient Monitor
- K150117 — Medtronic Patient Asistant
- K150310 — IntelliVue Patient Monitor
- K142352 — CardiacLinx
- K141441 — MENNTOR X7
- K132407 — VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
- K142180 — TELESENSE
- K140548 — CORCAM HEART MONITOR
- K131000 — V-PATCH SYSTEM
- K124060 — MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
- K121197 — BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
- K112921 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
- K120774 — ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
- K113125 — INTELLIVUE MX40 PATIENT MONITOR
- K111160 — INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
- K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
- K103764 — REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
- K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
- K103142 — SPACELABS MULTI-PARAMETER MODULE
- K102111 — MEDICAL MAGNETIC TAPE RECORDER
- K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
- K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
- K093766 — VITALOGIK 6000/6500
- K100155 — TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
- K092947 — TELESENTRY, MODEL TS01
- K091927 — INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
- K091971 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
- K090037 — MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
- K090834 — EPICARDIA 5000
- K083287 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
- K083517 — INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
- K082475 — REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
- K082633 — INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
- K081444 — BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
- K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
- K071889 — DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
- K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
- K071641 — REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
- K071655 — REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
- K073140 — VITALOGIK MODEL 4000/4500
- K071805 — NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
- K062976 — MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
- K070260 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
- K053263 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
- K052288 — VITALOGIK
- K052160 — ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
- K050919 — LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
- K050605 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
- K050175 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
- K024213 — SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
- K033305 — INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
- K032858 — THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
- K031433 — SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
- K032370 — CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
- K023798 — MODIFICATION TO ENVOY PATIENT MONITOR
- K020550 — PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
- K013046 — COSMOS SYSTEM
- K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
- K021376 — DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
- K021097 — QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
- K021300 — MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
- K021251 — ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
- K012467 — SOLAR 8000M SYSTEM
- K002604 — CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
- K020084 — FUKUDA DENSHI DYNASCOPE MODEL DS-5700
- K012241 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
- K014159 — PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR
- K012336 — MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
- K011339 — QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
- K012461 — SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
- K011784 — MODIFICATION TO ENVOY PATIENT MONITOR
- K011824 — AGILENT M2636B TELEMON B MONITOR (TELEMON B)
- K001120 — ENVOY PATIENT MONITOR
- K002758 — AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
- K002068 — ORG-9200A
- K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
- K003246 — SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
- K003179 — SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.