ClearanceBrief
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)
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Top companies in MHX

DateFirm and productCodeLinked 510(k)
Oct 16, 2026Philips North America
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Open, Classified
MHXNone listed
Oct 7, 2026Mindray DS USA, Inc.
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Open, Classified
MHXK190011
Oct 7, 2026Mindray DS USA, Inc.
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Open, Classified
MHXK153448
Oct 7, 2026Mindray DS USA, Inc.
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Open, Classified
MHXK153448
K190011
Oct 7, 2026Mindray DS USA, Inc.
BeneView Series. Operator's Manuals: T5 / T8
Open, Classified
MHXK092449
Oct 7, 2026Mindray DS USA, Inc.
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Open, Classified
MHXK213799
Oct 7, 2026Mindray DS USA, Inc.
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Open, Classified
MHXK260098
Oct 6, 2026Nihon 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
MHXK102376
Sep 22, 2026Criticare 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
MHXK030613
Sep 11, 2026Philips North America
Philips PIC iX Essentials REF:867093
Open, Classified
MHXK153702
Sep 11, 2026Philips North America
Philips Patient Information Center iX REF:866389
Open, Classified
MHXK153702
Aug 7, 2026Spacelabs 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
MHXK122146
Jul 2, 2026Masimo Corporation
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Open, Classified
MHXK223498
Jul 2, 2026Masimo Corporation
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Open, Classified
MHXK223498
Jun 24, 2026Philips 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
MHXK242962
May 28, 2026GE 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
MHXK103142
May 28, 2026GE 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
MHXK103142
May 28, 2026GE 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
MHXK103142
May 28, 2026GE 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
MHXK103142
May 28, 2026GE 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
MHXK103142
May 28, 2026GE 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
MHXK080251
Jan 22, 2026Edan 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
MHXK161056
Jan 22, 2026Edan 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
MHXK113653
Jan 22, 2026Edan 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
MHXK120727
K232694
Jan 22, 2026Edan 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
MHXK232962
Jan 22, 2026Edan 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
MHXK192514
Jan 22, 2026Edan 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
MHXK152552
Jan 22, 2026Edan 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
MHXK160981
Jan 22, 2026Edan 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
MHXK113623
K131971 +1
Jan 22, 2026Philips North America
Patient Information Center iX; Software Version Number: 4.5.0
Open, Classified
MHXK153702
Jan 8, 2026Philips North America Llc
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Open, Classified
MHXNone listed
Jan 8, 2026Remote 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
MHXK201746
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX850. Product Number: 866470.
Open, Classified
MHXK210906
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX750. Product Number: 866471.
Open, Classified
MHXK210906
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX550. Product Number: 866066.
Open, Classified
MHXK131872
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX500. Product Number: 866064.
Open, Classified
MHXK131872
Nov 7, 2025GE 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
MHXNone listed
Nov 7, 2025GE Healthcare Finland Oy
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Open, Classified
MHXK233810
Nov 7, 2025GE 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
MHXK213490
Nov 7, 2025GE 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
MHXK213234
Nov 7, 2025GE 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
MHXK213363
Oct 16, 2025Spacelabs 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
MHXK112962
K120616
Oct 16, 2025Spacelabs 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
MHXK112962
K120616
Oct 16, 2025Spacelabs 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
MHXK112962
K120616
Sep 29, 2025Schiller, Ag
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Open, Classified
MHXK221056
Sep 25, 2025Mindray 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
MHXK213799
Jul 25, 2025Remote 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
MHXK201746
May 14, 2025Contec Medical Systems Co., Ltd.
CMS8000 Patient Monitor
Open, Classified
MHXK101692
May 7, 2025Remote 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
MHXK201746
Apr 24, 2025Remote 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
MHXK130773
K201746

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