EBR SYSTEMS INC.

FDA Device Registration & Listing · Santa Clara, CA, US · Registration 3044322716

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3044322716
FEI Number
3044322716
Entity Name
EBR SYSTEMS INC.
City/State/Country
Santa Clara, CA, US
Establishment Address
4600 Patrick Henry Dr, Santa Clara, CA 95054, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
EBR Systems Inc. (Owner Number: 10092727)
Owner / Operator Contact Address
480 Oakmead Parkway, Sunnyvale, CA 94085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K053389
PMA Number
N/A

All Registered Proprietary Names

Steam Sterilization Top Container Surgical Forceps Retractor WiSE (Wireless Stimulation of the Endocardium Technology) CRT System Coupler Uterine Dilator Sterilization wrap Bottom Container

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2025-04-30
HTD Forceps General, Plastic Surgery Class 1 878.4800 2025-02-11
GAD Retractor General, Plastic Surgery Class 1 878.4800 2025-02-11
SEG Leadless Cardiac Resynchronization Therapy (Crt) Unknown Class 3 N/A 2025-04-30
QWA Cardiovascular Delivery Catheter System Positioning And Stabilization Device Cardiovascular Class 1 870.3955 2025-11-25
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2025-04-30
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2025-04-30

Official Correspondent

Pharoah Garma

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EBR Systems Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013596742 EBR SYSTEMS INC. Sunnyvale, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K021223 Sauter AG BELIMED STEAM STERILIZER, MODEL TOP 5000 2002-06-26
K050263 M.O. Com S.R.L. MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU 2006-11-21
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number Establishment Name Location
1219189 CONSOLIDATED MACHINE CORP. Billerica, MA, US
3005899764 STERIS MEXICO, S. de R.L. de C.V. GUADALUPE Nuevo Leon, MX
8030087 TUTTNAUER LTD. BEIT SHEMESH Jerusalem, IL
3022516928 DENT4YOU AG Heerbrugg Sankt Gallen, CH
3012068831 Getinge IC Production Poland sp. z o.o. Plewiska Wielkopolskie, PL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044322716. Last updated year: 2026. Please use registration number 3044322716 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.