STAT MEDICAL DEVICES, INC.

FDA Device Registration & Listing · North Miami Beach, FL, US · Registration 1058955

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
1058955
FEI Number
1000525253
Entity Name
STAT MEDICAL DEVICES, INC.
City/State/Country
North Miami Beach, FL, US
Establishment Address
2056 NE 153rd St, North Miami Beach, FL 33162, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
STAT MEDICAL DEVICES, INC. (Owner Number: 9020044)
Owner / Operator Contact Address
2056 NE 153rd Street, --, North Miami Beach, FL 33162, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K230310
PMA Number
N/A

All Registered Proprietary Names

ONE Drop Lancing Device STAT Super-Fine Insulin Pen Needle Standard STAT Super-Fine Insulin Pen Needle Xtra STAT Super-Fine Insulin Pen Needle Micro ULTIMATE Lancing Device TRIO Lancing Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-02-17
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-02-17
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2009-11-16
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-09-14
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STAT MEDICAL DEVICES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058955. Last updated year: 2026. Please use registration number 1058955 when referencing this establishment in official correspondence.
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