Vonco Products, LLC

FDA Device Registration & Listing · Fortville, IN, US · Registration 1834003

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
1834003
FEI Number
1000139922
Entity Name
Vonco Products, LLC
City/State/Country
Fortville, IN, US
Establishment Address
720 EAST BROADWAY, Fortville, IN 46040, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Vonco Products, LLC (Owner Number: 9006714)
Owner / Operator Contact Address
720 East Broadway, Fortville, IN 46040, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

READY-HEAT BLANKET Bioreactor and Cell Culture Mixing Bags Exhaust Collection Bag Thermazone; Sootheaway

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2016-12-28
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2013-11-18
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2009-04-07
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-02-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-02-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-02-29
KJF System, Suspension, Cell Culture Hematology Class 1 864.2240 2021-11-05
MNB Device, Thermal Ablation, Endometrial Unknown Class 3 N/A 2020-10-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-02-29
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2017-04-07

Official Correspondent

Margarita Nieves

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vonco Products, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1419562 VONCO PRODUCTS, LLC Trevor, WI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1834003. Last updated year: 2026. Please use registration number 1834003 when referencing this establishment in official correspondence.
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