Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2424366

FEI Number

2424366

Entity Name

FLEXBAR MACHINE CORP.

City/State/Country

ISLANDIA, NY, US

Establishment Address

250 GIBBS RD., ISLANDIA, NY 11749, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

FLEXBAR MACHINE CORP., dba Mediflex (Owner Number: 2424366)

Owner / Operator Contact Address

250 GIBBS RD., --, Islandia, NY 11749, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mediflex Reusable Electrodes LaproFlex DnyaTrac Retractor Frame Slide-Lock Graspers Micro-Grip Mediflex Knot Pushers Mediflex Needle Holders Skin Hooks Mediflex Cholangiography Catheter Mediflex Laparoscopic Tissue Retrieval Bag Mediflex Multi-Pupose Knot Pusher Mediflex Suture Grasper Closure Device SafePass Suture Grasper Device Surgeon's Sturgeon Mediflex FlexArm Mediflex StrongArm Mediflex Suture Passer Guide Bookler Table Mounted Retractor System FlexGuard Retractor Blade Cushion Lapro-Flex Universal Roundbar Retractor Mini-Bookler Retractor System Nathanson Liver Retractor Hooks Mediflex Laparoscopic Needle Holder Verres Needle Mediflex Retractor, Fiberoptic SUGITA HEADFRAME ADAPTER Mediflex Portland Trocars and Flexible Retractors Mediflex Container System Mediflex Cutting Edge Handle with Ratchet Mediflex Deluxe Laparoscopic Instruments Mediflex 3.5mm Laparoscopic Instruments Mediflex Airway Assist Mediflex One Piece Needle Holder Mediflex Clip Applier Mediflex Modular Needle Holder Mediflex Scope Warmer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2018-12-14
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2018-12-14
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2018-12-14
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1978-06-12
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2014-03-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-12-18
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2014-03-27
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-11-19
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2011-08-05
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-09-25
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-11-11
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1995-01-23
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2014-03-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-03-27
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2011-12-08
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-10-24
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2013-06-04
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-04-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-12-14
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-09-05
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-04-12

Official Correspondent

Keith Donaldson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FLEXBAR MACHINE CORP., dba Mediflex

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
K961841	C.R. Bard, Inc.	BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)	1996-10-09
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2424366. Last updated year: 2026. Please use registration number 2424366 when referencing this establishment in official correspondence.