Data / Medical devices / United States / Flexbar Machine Corp.

Flexbar Machine Corp.: FDA-registered device maker in Islandia, NY, United States, 8 510(k) clearances

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

Flexbar Machine Corp. is registered with the FDA (registration 2424366) in Islandia, NY, United States. It lists 26 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 11, 2013. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 2424366
Address: 250 Gibbs RD., Islandia, NY, United States, 11749
Owner or operator: FLEXBAR MACHINE CORP., dba Mediflex (2424366)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 12, 1978
Registered through: 2026
Brand names listed: Bookler Table Mounted Retractor System, CLAMP, Davida Neurological Retractor System, DnyaTrac Retractor Frame, FlexGuard Retractor Blade Cushion, Freehand, GREENBERG INSTRUMENT HOLDER, Lap-Rack and more

Devices it lists

Device	Product code	Class	Role	Source
Applier, Surgical, Clip	GDO	1	Repackager or relabeler	accessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-Disposable	FBM	1	Specification developer	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Repackager or relabeler	accessdata.fda.gov
Clamp	HXD	1	Contract manufacturer	accessdata.fda.gov
Electrode, Electrosurgical, Active, Urological	FAS	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gag, Mouth	KBN	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Laparoscopic Accessories, Gynecologic	NWV	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pneumoperitoneum Needle	FHO	2	Repackager or relabeler	accessdata.fda.gov
Resectoscope	FJL	2	Repackager or relabeler	accessdata.fda.gov
Resectoscope, Working Element	FDC	2	Repackager or relabeler	accessdata.fda.gov
Retainer, Surgical	GCZ	1	Complaint file establishment	accessdata.fda.gov
Retractor	GAD	1	Manufacturer, Specification developer	accessdata.fda.gov
Retractor, Fiberoptic	FDG	1	Specification developer	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Manufacturer	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Repackager or relabeler	accessdata.fda.gov
Support, Patient Position	CCX	1	Manufacturer	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	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
December 11, 2013	K123728	RETRIEVAL BAG	GCJ	Substantially Equivalent	Flexbar Machine Corp.	accessdata.fda.gov
February 28, 2011	K103840	CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE	GEI	Substantially Equivalent	Flexbar Machine Corp.	accessdata.fda.gov
December 30, 2010	K102663	AED RESECTOSCOPE	FJL	Substantially Equivalent	National Advanced Endoscopy Devices, Inc.	accessdata.fda.gov
November 18, 2010	K102146	BAHADIR STERILIZATION TRAYS	KCT	Substantially Equivalent	Bahadir USA Corp.	accessdata.fda.gov
May 22, 2009	K090340	FREEHAND	GCJ	Substantially Equivalent	Prosurgics Limited	accessdata.fda.gov
September 25, 2008	K081503	AED MONOPOLAR LAP ACCESSORIES	GEI	Substantially Equivalent	National Advanced Endoscopy Devices, Inc.	accessdata.fda.gov
April 21, 1998	K974382	ACKERMANN SURGICAL INSTRUMENTS	GCJ	Substantially Equivalent	Ackermann Instrumente GmbH	accessdata.fda.gov
July 23, 1993	K930474	NEEDLE, PNEUMOPERITONEUM, SPRING LOADED	FHO	Substantially Equivalent	Ranfac, Corp.	accessdata.fda.gov

Compare with other makers

Updated December 11, 2013. 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.