BENCHMARK ELECTRONICS, INC.

FDA Device Registration & Listing · WINONA, MN, US · Registration 2133641

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
2133641
FEI Number
3000203466
Entity Name
BENCHMARK ELECTRONICS, INC.
City/State/Country
WINONA, MN, US
Establishment Address
4065 THEURER BLVD., WINONA, MN 55987, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BENCHMARK ELECTRONICS, INC. (Owner Number: 1641405)
Owner / Operator Contact Address
56 S Rockford Dr., --, Tempe, AZ 85288, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown Class 3 N/A 2015-07-27
QRB Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy Unknown Class 3 N/A 2015-07-27
MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor Unknown Class 3 N/A 2016-12-21
NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Unknown Class 3 N/A 2016-12-21
PJS Stimulator, Electrical, Implanted, For Essential Tremor Unknown Class 3 N/A 2016-12-21
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2025-07-14
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-07-14
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2024-09-25
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2024-09-25
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-07-14
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-07-14
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-07-14
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2025-07-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-07-14
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-07-14
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-07-14
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2025-07-14
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-12-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-16
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-12-16
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2024-09-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-09-25
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2024-09-25
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2024-09-25
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2024-09-25
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2024-09-25
KZA Device, Vein Location, Liquid Crystal General Hospital Class 1 880.6970 2010-12-28
FLF Sterilizer, Ethylene-Oxide Gas General Hospital Class 2 880.6860 2015-02-17
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2021-06-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-06-05
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2021-11-02
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2021-11-02
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2025-07-14
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-07-14
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-07-14
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-07-14
QEM Cerebral Oximeter Cardiovascular Class 2 870.2700 2025-07-14
QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-07-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-07-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-07-14
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2025-07-14
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-07-14
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2021-11-02
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2021-11-02
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2021-11-02
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2021-11-02
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2021-11-02
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2024-09-25
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2024-09-25
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2024-09-25
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2024-09-25
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2024-09-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-09-25
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2024-09-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-09-25
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-03-18
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-03-25
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2022-03-25
OUG Medical Device Data System General Hospital Class 1 880.6310 2021-11-02
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-07-16
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2017-11-27
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2024-09-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-09-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-09-25
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2024-09-25
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2024-09-25
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2024-09-25
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2024-09-25
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2024-09-25
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2020-03-18
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2018-12-17
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2018-12-17
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2018-12-17
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2021-11-02
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2021-11-02
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2021-11-02
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2021-11-02
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2021-11-02
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2025-07-14
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2006-07-12
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2006-07-12
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2006-07-12
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2006-07-12
OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Unknown Class 3 N/A 2006-07-12
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2006-07-12
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2006-07-12
FOX Stand, Infusion General Hospital Class 1 880.6990 2024-09-25
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2022-12-13
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2022-12-13
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2022-12-13
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2022-12-13
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-12-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-12-13
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2017-06-15
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2017-06-15
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2015-12-09
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2014-12-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-12-16
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2020-07-16
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2020-07-16
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-07-16
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2020-07-16
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2021-06-05
PNJ Leadless Pacemaker Cardiovascular Class 3 870.3610 2022-06-15
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2021-11-02
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2021-11-02
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2021-11-02
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2021-11-02
LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable Unknown Class 3 N/A 2021-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BENCHMARK ELECTRONICS, 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
3044741637 Benchmark Almelo Almelo Overijssel, NL
3003899230 BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LI AYUDHAYA Phra Nakhon Si Ayutthaya, TH
3037724692 BENCHMARK ELECTRONICS San Jorge Tlajomulco de Zuniga Jalisco, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26
K052355 U-Systems, Inc. AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS 2005-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2018 St. Jude Medical, Inc. 3
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018 St. Jude Medical, Inc. 3
Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013 Advanced Neuromodulation Systems Inc. 3
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026 Abbott Medical 3
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024 Abbott Medical 3
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133641. Last updated year: 2026. Please use registration number 2133641 when referencing this establishment in official correspondence.
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