Recorder, Magnetic Tape, Medical
Cardiovascular · 21 CFR 870.2800
Recent MDR events
962 adverse event reports on file
- CAM SYSTEMJul 21, 2026InjuryBardy Diagnostics, Inc.3014226707-2026-00007
- EPATCH 2.5, BTHJul 17, 2026InjuryBraemar Manufacturing, Llc2133409-2026-00133
- ZIO MONITOR BY IRHYTHMJul 16, 2026InjuryIrhythm Technologies, Inc.MW5190744
- ZIO HEART MONITORJul 13, 2026InjuryIrhythm Technologies, Inc.MW5190617
- ZIO LONG-TERM CONTINUOUS HEART MONITORJul 6, 2026InjuryIrhythm Technologies Inc.MW5190275
- CAM SYSTEMJul 2, 2026InjuryBardy Diagnostics, Inc.3014226707-2026-00005
- CAM SYSTEMJun 12, 2026InjuryBardy Diagnostics, Inc.3014226707-2026-00004
- EPATCH 2.5, BTHJun 11, 2026MalfunctionBraemar Manufacturing, Llc2133409-2026-00103
- RECORDER, MAGNETIC TAPE, MEDICALJun 9, 2026MalfunctionIrhythm Technologies, Inc.MW5189120
- ZIO MONITORJun 4, 2026InjuryIrhythm Technologies, Inc.MW5188946
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
110 firms currently registered for this product code
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Cardiac Insight, Inc.
Bellevue, WA, US
Vitalograph Ireland Ltd.
Co Clare, IE
Biox Instruments Co Ltd
Wuxi Jiangsu, CN
Emsere Bv
Leiden Zuid-Holland, NL
Strados Labs Inc.
Marietta, GA, US
Irhythm Technologies, Inc.
Cypress, CA, US
Qualitel Corporation
Everett, WA, US
Philips North America Llc
Export, PA, US
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Shenzhen Creative Industry Co., Ltd
SHENZHEN Guangdong, CN
Dms-service Llc
Los Angeles, CA, US
Edan Instruments, Inc.
Shenzhen Guangdong, CN
Philips North America Llc
Cambridge, MA, US
Bernd Richter Gmbh
Wipperfuerth North Rhine-Westphalia, DE
Philips Electronics Ltd
Mississauga Ontario, CA
Dreamtech Vietnam Co., Ltd
Tu Son Ward Bac Ninh, VN
Cardionet, Llc
Linwood, PA, US
Icon Llc
Rochester, NY, US
Cardiocomm Solutions, Inc.
North York Ontario, CA
Peerbridge Health, Inc.
Franklin, TN, US
Somnomedics Ag
RANDERSACKER Bavaria, DE
Scottcare Corporation
CLEVELAND, OH, US
510(k) clearances
195 clearances for this product code
- LifeLens Technologies, Inc.Jul 9, 2026
K260157 · LifeLens Physiological Monitor
- Smwmed, Inc.Apr 23, 2026
K252389 · Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
- Vitalograph , Ltd.Dec 3, 2025
K253293 · VitaloJAK Clinic (Model 7100)
- iRhythm Technologies, Inc.Aug 15, 2025
K243650 · Zio® monitor (DFG0001)
- Aevice Health Pte. , Ltd.May 5, 2025
K243603 · AeviceMD
- Atsens Co., Ltd.May 2, 2025
K242583 · AT-Patch (ATP-C130/ATP-C70)
- MEZOO Co., Ltd.Sep 20, 2024
K232670 · HiCardi+ H100
- Wellysis Corp.Feb 16, 2024
K233906 · S-Patch (S-Patch ExL)