Company
WELCH ALLYN, INC/MORTARA
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DPS | Electrocardiograph | 16 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2021 | Welch Allyn Inc Mortara ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers:
ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX,
ELI280-BCB- Open, Classified |
DPS | K122073 |
| Mar 31, 2021 | Welch Allyn Inc Mortara AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. Terminated |
DPS | None listed |
| Mar 31, 2021 | Welch Allyn Inc Mortara Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric po Terminated |
DPS | K173765 |
| Mar 31, 2021 | Welch Allyn Inc Mortara ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. Terminated |
DPS | K142105 |
| Mar 31, 2021 | Welch Allyn Inc Mortara ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. Terminated |
DPS | K122073 |
| Nov 11, 2020 | WELCH ALLYN, INC/MORTARA ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from e Terminated |
DPS | None listed |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GR Terminated |
DPS | None listed |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system. Terminated |
DPS | K041607 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquis Terminated |
DPS | K152944 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW.
The Surveyor S12 patient monitor Terminated |
DPS | K173765 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AH Terminated |
DPS | K160685 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LE Terminated |
DPS | K974149 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient Terminated |
DPS | K081800 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10 Terminated |
DPS | K050896 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files. Terminated |
DPS | K093339 |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio.
Product Usage: A non-invasive prescr Terminated |
DPS | K092663 K100127 +3 |