Stethoscope, Electronic
Cardiovascular · 21 CFR 870.1875
Recent MDR events
5 adverse event reports on file
- EKO ELECTRONIC STETHOSCIPE SYSTEMMay 8, 2026MalfunctionEko Health, Inc.3011651230-2026-00001
- CORE 500 DIGITAL STETHOSCOPENov 12, 2024MalfunctionEko Health, Inc.3011651230-2024-00001
- 3M LITTMANN ELECTRONIC STETHOSCOPENov 12, 2013Other3m Health Care2110898-2013-00071
- HS III PROXIMAL SEAL SYSTEM 4.3MMOct 13, 2011MalfunctionMaquet Cardiovascular, Llc2242352-2011-01526
- BARDAug 26, 2004MalfunctionBard Acess SystemsMW1033092
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
70 firms currently registered for this product code
Jedmed Instrument Company
Saint Louis, MO, US
American Diagnostic Corp.
HAUPPAUGE, NY, US
Medwand Solutions, Inc
RSM, CA, US
Eko Health, Inc.
Emeryville, CA, US
Heroic Faith International Ltd.
TAIPEI CITY, TW
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Withings
Issy-les-Moulineaux Ile-de-France, FR
Ionics Ems, Inc-plant 2
Calamba City Laguna, PH
Ya Horng Electronic Co., Ltd.
Tainan, TW
Tecan Cdmo Solutions Pn Sdn. Bhd.
Penang Pulau Pinang, MY
Ionics Ems Inc.
Cabuyao City Laguna, PH
Echonous, Inc.
Redmond, WA, US
East West Wisconsin
WHITEWATER, WI, US
Dictum Health, Inc.
Malibu, CA, US
Alivecor
Mountain View, CA, US
Nextphase Medical Devices, Llc
MANSFIELD, MA, US
Cbr Enterprise Limited
Hong Kong, HK
Millstone Medical Outsourcing Llc
Olive Branch, MS, US
Master Wave Technology Co., Ltd. Dba Sheng Yih Technologies Co., Ltd.
Zhongli District Taoyuan, TW
Innokas Medical Estonia Ou
Tallinn Harjumaa, EE
Globalmed Holdings, Llc
Scottsdale, AZ, US
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
Thinklabs Medical Llc
Englewood, CO, US
510(k) clearances
156 clearances for this product code
- Shanghai Hulu Devices Co., Ltd.Jul 31, 2026
K261494 · Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)
- Eko Health, Inc.Jul 23, 2026
K261694 · CORE 300 Digital Stethoscope
- Ai Health Highway India Pvt., Ltd.May 22, 2026
K252915 · AiSteth®
- Tyto Care , Ltd.Mar 12, 2026
K252089 · Tyto Stethoscope (G3)
- Kneevoice, Inc.Feb 6, 2026
K252076 · Kneevoice Cartilage Evaluation System (750-3600-001)
- Csd LabsDec 19, 2025
K252284 · eMurmur Heart AI
- Sparrow Acoustics, Inc.Sep 12, 2025
K252595 · Stethophone Pro
- Eko Health, Inc.Aug 12, 2025
K251494 · Eko Foundation Analysis Software with Transformers (EFAST)