Data / Medical devices / United States / Prabadin Corp

Prabadin Corp: FDA-registered device maker in Miami, FL, United States, 3 510(k) clearances

Name: Prabadin Corp FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Prabadin Corp is registered with the FDA (registration 3016659819) in Miami, FL, United States. It lists 31 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 23, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016659819
Address: 13800 SW 119 Ave, Miami, FL, United States, 33186
Owner or operator: PRABADIN CORP (10093506)
Roles: Complaint file establishment
First device listed: May 27, 2025
Registered through: 2026
Brand names listed: Anti Embolism Stockings, CAUTERY PUSH BUTTON, Cannula Aspirating Needle Disposable, DRAPE, Disposable Surgical Pack, Disposable Surgical Tray, Drug Cup Test Multiple, Gauze / sponge,nonresorbable for external use and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Complaint file establishment	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Complaint file establishment	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Complaint file establishment	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Complaint file establishment	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Complaint file establishment	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Complaint file establishment	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Complaint file establishment	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Complaint file establishment	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Complaint file establishment	accessdata.fda.gov
Marker, Skin	FZZ	1	Complaint file establishment	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Complaint file establishment	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Complaint file establishment	accessdata.fda.gov
Plastic Surgery And Accessories Kit	FTN	1	Complaint file establishment	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Complaint file establishment	accessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	2	Complaint file establishment	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Complaint file establishment	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Complaint file establishment	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Complaint file establishment	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Complaint file establishment	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Complaint file establishment	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Complaint file establishment	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Complaint file establishment	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Complaint file establishment	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Complaint file establishment	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Complaint file establishment	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Complaint file establishment	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Complaint file establishment	accessdata.fda.gov
Tray, Surgical	LRP	1	Complaint file establishment	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Complaint file establishment	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 23, 2022	K221815	Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)	GEI	Substantially Equivalent	Baisheng Medical Co., Ltd.	accessdata.fda.gov
April 5, 2018	K180349	AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	NFT	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
February 24, 2016	K152768	Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip	JHI	Substantially Equivalent	Assure Tech. Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.