Panels › Cardiovascular › Product code MHX · Class 2
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation 870.1025
16510(k)s in 12 months (431 all time)
41recalls in 12 months (294 all time)
277recalls that name a 510(k)
Top companies in MHX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | Philips North America Philips Smart-hopping 2.0 AP 1.4 GHz;
Product/Model Number: 867216; Open, Classified |
MHX | None listed |
| Oct 7, 2026 | Mindray DS USA, Inc. T1 Patient Monitor. Operator's Manual: T1 Patient Monitor Open, Classified |
MHX | K190011 |
| Oct 7, 2026 | Mindray DS USA, Inc. cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 Open, Classified |
MHX | K153448 |
| Oct 7, 2026 | Mindray DS USA, Inc. Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V Open, Classified |
MHX | K153448 K190011 |
| Oct 7, 2026 | Mindray DS USA, Inc. BeneView Series. Operator's Manuals: T5 / T8 Open, Classified |
MHX | K092449 |
| Oct 7, 2026 | Mindray DS USA, Inc. BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. Open, Classified |
MHX | K213799 |
| Oct 7, 2026 | Mindray DS USA, Inc. ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A Open, Classified |
MHX | K260098 |
| Oct 6, 2026 | Nihon Kohden America LLC 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, 02-10, 02-11, and 02-40
Product Descrip Open, Classified |
MHX | K102376 |
| Sep 22, 2026 | Criticare Technologies, Inc. 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 Open, Classified |
MHX | K030613 |
| Sep 11, 2026 | Philips North America Philips PIC iX Essentials
REF:867093 Open, Classified |
MHX | K153702 |
| Sep 11, 2026 | Philips North America Philips Patient Information Center iX
REF:866389 Open, Classified |
MHX | K153702 |
| Aug 7, 2026 | Spacelabs Healthcare, Inc. Brand Name: Xhibit
Product Name: Xhibit Central Station
Model/Catalog Number: 96102
Software Version: N/A
Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Open, Classified |
MHX | K122146 |
| Jul 2, 2026 | Masimo Corporation Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 Open, Classified |
MHX | K223498 |
| Jul 2, 2026 | Masimo Corporation Radius VSM ECG pre-connected Set, REF: 4842, 4695 Open, Classified |
MHX | K223498 |
| Jun 24, 2026 | Philips North America Llc Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX. Open, Classified |
MHX | K242962 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia D Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physio Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Pati Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patien Open, Classified |
MHX | K103142 |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Open, Classified |
MHX | K080251 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Telemetry Transmitter
Model/Catalog Number: iT20
Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing Open, Classified |
MHX | K161056 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM8, iM8A, iM8B
Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiologic Open, Classified |
MHX | K113653 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Central Monitoring System
Model/Catalog Number: MFM-CMS
Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information fro Open, Classified |
MHX | K120727 K232694 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iX10, iX12, iX15
Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous mo Open, Classified |
MHX | K232962 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: X8, X10, X12
Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous mon Open, Classified |
MHX | K192514 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM20
Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of Open, Classified |
MHX | K152552 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: elite V5, elite V6, elite V8
Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perf Open, Classified |
MHX | K160981 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM50, iM60, iM70, iM80
Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time Open, Classified |
MHX | K113623 K131971 +1 |
| Jan 22, 2026 | Philips North America Patient Information Center iX;
Software Version Number: 4.5.0 Open, Classified |
MHX | K153702 |
| Jan 8, 2026 | Philips North America Llc Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. Open, Classified |
MHX | None listed |
| Jan 8, 2026 | Remote Diagnostic Technologies Ltd. Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R.
USB 2-Channel IBP Module, REF: 01-2017.
Used with User/Operator Manual Open, Classified |
MHX | K201746 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX850. Product Number: 866470. Open, Classified |
MHX | K210906 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX750. Product Number: 866471. Open, Classified |
MHX | K210906 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX550. Product Number: 866066. Open, Classified |
MHX | K131872 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX500. Product Number: 866064. Open, Classified |
MHX | K131872 |
| Nov 7, 2025 | GE Healthcare Finland Oy BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS
used with affected patient monitors
Model No 2062895-001
Manufacturer Part Number U80296-1R01, revision S Open, Classified |
MHX | None listed |
| Nov 7, 2025 | GE Healthcare Finland Oy Portrait VSM
Model nos.
6660000-666
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms Open, Classified |
MHX | K233810 |
| Nov 7, 2025 | GE Healthcare Finland Oy B105P, B125P, B105M, B125M, B155M Patient Monitors;
Model nos.
6160000-002
6160000-003
6160000-004
6160000-005
6160000-101
6160000-102
6160000-103
6160000-104
6160000-105
6160001-063
6160001-064
6160 Open, Classified |
MHX | K213490 |
| Nov 7, 2025 | GE Healthcare Finland Oy CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms Open, Classified |
MHX | K213234 |
| Nov 7, 2025 | GE Healthcare Finland Oy Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms
R Open, Classified |
MHX | K213363 |
| Oct 16, 2025 | Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0893-01
Software Version: N/A
Product Description: 16 inch DVI-I to DVI-I male/male disp Open, Classified |
MHX | K112962 K120616 |
| Oct 16, 2025 | Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0895-12
Software Version: N/A
Product Description: 12 foot DVI-I to DVI-I male/male disp Open, Classified |
MHX | K112962 K120616 |
| Oct 16, 2025 | Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0895-01
Software Version: N/A
Product Description: 6 foot DVI-I to DVI-I male/male displ Open, Classified |
MHX | K112962 K120616 |
| Sep 29, 2025 | Schiller, Ag Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 Open, Classified |
MHX | K221056 |
| Sep 25, 2025 | Mindray DS USA, Inc. dba Mindray North America BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, Open, Classified |
MHX | K213799 |
| Jul 25, 2025 | Remote Diagnostic Technologies Ltd. Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R Open, Classified |
MHX | K201746 |
| May 14, 2025 | Contec Medical Systems Co., Ltd. CMS8000 Patient Monitor Open, Classified |
MHX | K101692 |
| May 7, 2025 | Remote Diagnostic Technologies Ltd. Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R,
00-1026-R, 00-1004, 00-1007 Open, Classified |
MHX | K201746 |
| Apr 24, 2025 | Remote Diagnostic Technologies Ltd. Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer) Open, Classified |
MHX | K130773 K201746 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.