ClearanceBrief
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

CodeDeviceRecords
DPSElectrocardiograph16

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 3, 2021Welch 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
DPSK122073
Mar 31, 2021Welch 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
DPSNone listed
Mar 31, 2021Welch 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
DPSK173765
Mar 31, 2021Welch 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
DPSK142105
Mar 31, 2021Welch 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
DPSK122073
Nov 11, 2020WELCH 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
DPSNone listed
Apr 29, 2020WELCH 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
DPSNone listed
Apr 29, 2020WELCH ALLYN, INC/MORTARA
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
Terminated
DPSK041607
Apr 29, 2020WELCH 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
DPSK152944
Apr 29, 2020WELCH 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
DPSK173765
Apr 29, 2020WELCH 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
DPSK160685
Apr 29, 2020WELCH 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
DPSK974149
Apr 29, 2020WELCH 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
DPSK081800
Apr 29, 2020WELCH 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
DPSK050896
Apr 29, 2020WELCH 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
DPSK093339
Apr 29, 2020WELCH 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
DPSK092663
K100127 +3
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