Company ยท US
Ivy Biomedical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2024. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 10 |
| DPS | Electrocardiograph | 4 |
| DQA | Oximeter | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 13, 2024 | K240087 | RT Carbon ECG Leads Ivy Biomedical Systems, Inc. | DSA |
| May 14, 2021 | K202138 | Cardiac Trigger Monitor Ivy Biomedical Systems, Inc. | DRT |
| Mar 2, 2021 | K203653 | MRI PPG Patient Cable Ivy Biomedical Systems, Inc. | LNH |
| Mar 28, 2020 | K192852 | MRI ECG Patient Cable Ivy Biomedical Systems, Inc. | LNH |
| Mar 14, 2018 | K171778 | MR Wireless Gating System, Model WGS-100 Ivy Biomedical Systems, Inc. | LNH |
| May 17, 2017 | K170828 | Cardiac Trigger Monitor Ivy Biomedical Systems, Inc. | DRT |
| May 27, 2016 | K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor Ivy Biomedical Systems, Inc. | DRT |
| Jul 22, 2011 | K110987 | CARDIAC TRIGGER MONITOR Ivy Biomedical Systems, Inc. | DRT |
| Oct 9, 2009 | K091787 | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR Ivy Biomedical Systems, Inc. | DQA |
| Jul 24, 2009 | K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE Ivy Biomedical Systems, Inc. | DRT |
| Feb 13, 2009 | K083854 | CARDIAC TRIGGER, MODEL: CTM300 Ivy Biomedical Systems, Inc. | DRT |
| Nov 4, 2002 | K023616 | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) Ivy Biomedical Systems, Inc. | DRT |
| Oct 22, 1998 | K982255 | MODEL 2000 PULSE OXIMETER Ivy Biomedical Systems, Inc. | DQA |
| May 14, 1997 | K964961 | MODEL 405T WITH ETCO2 OPTION Ivy Biomedical Systems, Inc. | CCK |
| Aug 16, 1996 | K955546 | PATIENT MONITOR MODEL 405P Ivy Biomedical Systems, Inc. | DPS |
| Jul 13, 1995 | K945099 | PARAMETERS MONITORES Ivy Biomedical Systems, Inc. | MHX |
| Mar 25, 1992 | K912139 | MODEL 704 Ivy Biomedical Systems, Inc. | GWM |
| Mar 1, 1991 | K904606 | MODEL 405 Ivy Biomedical Systems, Inc. | DPS |
| Aug 23, 1990 | K901504 | MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. Ivy Biomedical Systems, Inc. | DQA |
| Mar 9, 1989 | K884455 | MODEL 702 ECG/RESPIRATION/TEMPERATURE Ivy Biomedical Systems, Inc. | DRT |
| Feb 23, 1989 | K884096 | PATIENT MONITOR MODEL 701 Ivy Biomedical Systems, Inc. | DRT |
| Feb 2, 1989 | K884662 | PATIENT MONITOR MODEL 703 Ivy Biomedical Systems, Inc. | DPS |
| Aug 2, 1988 | K882118 | MODEL 700 PATIENT MONITOR Ivy Biomedical Systems, Inc. | DRS |
| Jul 28, 1988 | K882188 | MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR Ivy Biomedical Systems, Inc. | DXN |
| Mar 22, 1988 | K880066 | MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR Ivy Biomedical Systems, Inc. | DRT |
| Aug 18, 1986 | K862647 | PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 Ivy Biomedical Systems, Inc. | DSK |
| May 7, 1986 | K854840 | PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A Ivy Biomedical Systems, Inc. | DPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||