Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeMWI
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMC HEALTH
  SUBSTANTIALLY EQUIVALENT 1
ANALOG DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ANALOG DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATHENA GTX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP/ EXCEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAPSULE SURVEILLANCE TECHNOLOGIES, SAS /CAPSULE TECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAPSULE TECHNOLOGIE SAS
  SUBSTANTIALLY EQUIVALENT 1
CASANA CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGE HEALTHCARE ISRAEL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
COSINUSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EMPATICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
FYSICON BV
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
HAPPY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
IHEALTH LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INFINIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL AS
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDOPAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWAND SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MULTISENSOR DIAGNOSTICS (DBA AIDAR HEALTH)
  SUBSTANTIALLY EQUIVALENT 1
ORDINATRUM SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TALIS CLINICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WARD 24/7 APS
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZOE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 188 188
2022 168 173
2023 179 179
2024 120 120
2025 184 184
2026 437 437

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Shutdown 240 240
Incorrect Measurement 127 128
Sensing Intermittently 89 89
Device Alarm System 84 84
No Audible Alarm 80 80
Incorrect, Inadequate or Imprecise Result or Readings 56 56
Failure to Power Up 47 47
Display or Visual Feedback Problem 44 44
Break 38 38
Application Program Freezes or Fails to Launch 37 37
Low Readings 36 36
Inappropriate or Unexpected Reset 35 35
Communication or Transmission Problem 33 33
Intermittent Loss of Power 32 32
Sparking 32 32
Device Displays Incorrect Message 30 30
Defective Alarm 30 30
Pitted 30 30
Key or Button Unresponsive/not Working 30 30
Fire 22 22
Insufficient Device Problem Information 22 22
High Readings 22 22
Overheating of Device 21 21
Computer Software Problem 16 16
Unable to Obtain Readings 16 16
Flare or Flash 14 14
No Audible Prompt/Feedback 12 12
Imprecise or Erratic Results 12 12
Erratic or Intermittent Display 11 11
Defibrillation/Stimulation Problem 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Smoking 11 11
Device Sensing Problem 10 10
Detachment of Device or Device Component 9 9
Electrical Shorting 8 8
Application Program Problem 8 8
Electrical /Electronic Property Problem 7 7
Thermal Decomposition of Device 7 7
Wireless Communication Problem 7 7
Unintended Electrical Shock 7 7
Operating System Becomes Nonfunctional 7 7
Measurement System Incompatibility 6 6
Failure to Sense 6 6
Loose or Intermittent Connection 6 6
Premature Discharge of Battery 5 5
Explosion 5 5
No Display/Image 5 5
Material Split, Cut or Torn 5 5
Temperature Problem 4 4
No Device Output 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1172 1175
Insufficient Information 64 64
Electric Shock 9 9
Cardiac Arrest 7 7
Burn(s) 4 4
Erythema 3 3
Respiratory Arrest 2 2
Discomfort 2 4
Laceration(s) 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
No Consequences Or Impact To Patient 2 2
Bruise/Contusion 2 2
Non specific EKG/ECG Changes 1 1
Encephalopathy 1 1
Superficial (First Degree) Burn 1 1
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Brain Injury 1 1
Skin Disorders 1 1
Easy Bruising 1 1
Skin Discoloration 1 1
Increased Level of Consciousness 1 1
Ventricular Fibrillation 1 1
Loss Of Pulse 1 1
Valvular Stenosis 1 3
Asystole 1 1
Shock 1 1
Swelling/ Edema 1 1
Hypoxia 1 1
Myocardial Infarction 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Heart Problem 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Full thickness (Third Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 A L I Technologies Ltd II Jan-16-2025
2 Baxter Healthcare Corporation II Apr-15-2025
3 Baxter Healthcare Corporation II Apr-14-2025
4 Baxter Healthcare Corporation II Sep-12-2023
5 CHANGE HEALTHCARE CANADA COMPANY II Jul-02-2025
6 CHANGE HEALTHCARE CANADA COMPANY II Oct-17-2024
7 Covidien LLC II Mar-11-2026
8 Edan Diagnostics II Jan-22-2026
9 GE Medical Systems Information Technologies Inc II Aug-27-2026
10 GE Medical Systems Information Technologies Inc II Aug-04-2026
11 GE Medical Systems, LLC II Jan-15-2025
12 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-30-2024
13 Philips North America Llc II Oct-04-2022
14 Philips North America Llc II May-06-2022
15 Philips North America Llc II Apr-29-2021
16 Spectrum Medical Ltd. II Apr-29-2025
-
-