Device type
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Product code MHX · Class II · 21 CFR 870.1025 · Cardiovascular
Recent 510(k)s
Oct 14, 2026
K260676
Radius VSM and Accessories
Masimo Corporation
- MHX
- Class II
Sep 1, 2026
K260656
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M
GE Healthcare Finland Oy
- MHX
- Class II
Aug 28, 2026
K260343
Carescape Canvas 1000; Carescape Canvas Smart Display
GE Healthcare Finland Oy
- MHX
- Class II
Aug 20, 2026
K260579
Infinity® Acute Care System (IACS) – VG8.1
Draeger Medical Systems, Inc.
- MHX
- Class II
Recent recalls
Oct 28, 2026
Z-0199-2027
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Philips North America
- MHX
- Class II
- Ongoing
Oct 14, 2026
Z-0110-2027
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0113-2027
BeneView Series. Operator's Manuals: T5 / T8
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0116-2027
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0114-2027
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0089-2027
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06…
Nihon Kohden America LLC
- MHX
- Class II
- Ongoing
Oct 14, 2026
Z-0109-2027
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0115-2027
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Sep 30, 2026
Z-3253-2026
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R
Criticare Technologies, Inc.
- MHX
- Class II
- Ongoing
Sep 23, 2026
Z-3142-2026
Philips PIC iX Essentials REF:867093
Philips North America
- MHX
- Class II
- Ongoing
Sep 23, 2026
Z-3141-2026
Philips Patient Information Center iX REF:866389
Philips North America
- MHX
- Class II
- Ongoing