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Medical Disposables Corp: FDA-registered device maker in Orlando, FL, United States, 8 510(k) clearances

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

Medical Disposables Corp is registered with the FDA (registration 3009212837) in Orlando, FL, United States. It lists 26 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 5, 2018. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009212837
Address: 6831 Edgewater Commerce Pkwy Ste 1101, Orlando, FL, United States, 32810
Owner or operator: Medical Disposables Corp (10055555)
Roles: Complaint file establishment, Manufacturer for export, Repackager or relabeler
First device listed: September 5, 2019
Registered through: 2027
Brand names listed: EndoGuidance Monopolar Laparascopic Accessories, EndoGuidance Specimen Retrieval Bag, EndoGuidance Suction Irrigation System, EndoGuidance Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Troca, EndoGuidance Veress Needle, MD DrugScreen Test, MD DrugScreen Test Cup, MD SalivaScreen

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Pneumoperitoneum Needle	FHO	2	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Complaint file establishment, Manufacturer for export, Repackager or relabeler	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
April 5, 2018	K180349	AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	NFT	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
August 2, 2017	K163704	Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
May 23, 2016	K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
August 10, 2015	K141594	Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar	GCJ	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
July 31, 2015	K150068	Unimicro Veress Needle	HIF	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
April 13, 2015	K142208	Monopolar Laparascopic Accessories	GEI	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
November 13, 2014	K141593	UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH	GCJ	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
August 4, 2014	K141592	UNIMICRO SUCTION IRRIATION TUBING SET	GCJ	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov

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Updated April 5, 2018. 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.