Flexbar Machine Corp

FDA Filings

This page includes the latest FDA filings for Flexbar Machine Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Flexbar Machine Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• FREEHAND 2010 Ltd

FDA Registration(s)

• Registration Number: 2424366
• FEI Number: 2424366
• Name: FLEXBAR MACHINE CORP.
• Owner & Operator: FLEXBAR MACHINE CORP., dba Mediflex
• Contact Address: 250 GIBBS RD. --; Islandia NY 11749 US
• Official Correspondent:
  • Keith P Donaldson
  • x-631-5828440-345
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 250 GIBBS RD. ; ISLANDIA, NY 11749 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00842102115837 FLEXBAR MACHINE CORPORATION	DynaTrac Retractor Frame	2024-04-04
GUDID 00842102115820 FLEXBAR MACHINE CORPORATION	TORS	2024-03-25
GUDID 00842102115813 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2024-03-11
GUDID 00842102115806 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2024-03-11
GUDID 00842102115790 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115783 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115776 FLEXBAR MACHINE CORPORATION	Trays	2024-03-06
GUDID 00842102115769 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115752 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115745 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115738 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115721 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115714 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115707 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2024-03-06
GUDID 00842102115691 FLEXBAR MACHINE CORPORATION	Holders and Positioners - Nathanson Hooks	2024-03-06
GUDID 00842102115684 FLEXBAR MACHINE CORPORATION	Holders and Positioners - Nathanson Hooks	2024-03-06
GUDID 00842102115677 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2024-02-29
GUDID 00842102115660 FLEXBAR MACHINE CORPORATION	DynaTrac Retractor Frame	2024-02-23
GUDID 00842102115653 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-02-09
GUDID 00842102115646 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-02-09
GUDID 00842102115639 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-02-09
GUDID 00842102115622 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-02-09
GUDID 00842102115615 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-02-09
GUDID 00842102115608 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115592 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115585 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115578 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115561 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115554 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115547 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115530 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2024-01-25
GUDID 00842102115523 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-01-19
GUDID 00842102115516 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-01-19
GUDID 00842102115509 FLEXBAR MACHINE CORPORATION	Holders and Positioners - Nathanson Hooks	2024-01-10
GUDID 00842102115493 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2024-01-05
GUDID 00842102115486 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2023-11-30
GUDID 00842102115479 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2023-11-30
GUDID 00842102115462 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2023-11-15
GUDID 00842102115455 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2023-10-19
GUDID 00842102115448 FLEXBAR MACHINE CORPORATION	Holders and Positioners - Nathanson Hooks	2023-10-11
GUDID 00842102115431 FLEXBAR MACHINE CORPORATION	Holders and Positioners - Nathanson Hooks	2023-10-11
GUDID 00842102115424 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2023-07-18
GUDID 00842102115417 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2023-07-18
GUDID 00842102115400 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2023-07-18
GUDID 00842102115394 FLEXBAR MACHINE CORPORATION	Trays	2023-07-03
GUDID 00842102115387 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2023-06-27
GUDID 00842102115370 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2023-06-27
GUDID 00842102115363 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2023-06-27
GUDID 00842102115325 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2023-05-04
GUDID 00842102115318 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2023-04-28
GUDID 00842102115301 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2023-04-28
GUDID 00842102115295 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2023-04-13
GUDID 00842102115288 FLEXBAR MACHINE CORPORATION	Trays	2023-04-11
GUDID 00842102115271 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2023-03-13
GUDID 00842102115264 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2023-03-13
GUDID 00842102115257 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2023-03-13
GUDID 00842102115240 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2023-03-13
GUDID 00842102115233 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2023-03-13
GUDID 00842102115226 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2023-03-13
GUDID 00842102115219 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2023-03-13
GUDID 00842102115134 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2022-11-16
GUDID 00842102115127 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-11-07
GUDID 00842102115110 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-11-07
GUDID 00842102115103 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-11-07
GUDID 00842102115097 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-11-07
GUDID 00842102115080 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-11-07
GUDID 00842102115073 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-10-18
GUDID 00842102115066 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-09-12
GUDID 00842102115059 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2022-08-19
GUDID 00842102115042 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2022-08-19
GUDID 00842102115035 FLEXBAR MACHINE CORPORATION	StrongArm Surgical Holders and Positioners	2022-08-15
GUDID 00842102115028 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-07-22
GUDID 00842102115011 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-07-22
GUDID 00842102115004 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114991 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114984 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114977 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114960 FLEXBAR MACHINE CORPORATION	Mini-Bookler Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114953 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114946 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114939 FLEXBAR MACHINE CORPORATION	Bookler Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114922 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2022-07-22
GUDID 00842102114915 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2022-06-21
GUDID 00842102114908 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2022-06-15
GUDID 00842102114892 FLEXBAR MACHINE CORPORATION	Trays	2022-01-18
GUDID 00842102114885 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2021-12-10
GUDID 00842102114878 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2021-12-10
GUDID 00842102114861 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2021-12-10
GUDID 00842102114854 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2021-12-10
GUDID 00842102114847 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2021-12-10
GUDID 00842102114830 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2021-12-08
GUDID 00842102114823 FLEXBAR MACHINE CORPORATION	Mediflex Universal Round Bar Table Mounted Retractor Systems	2021-12-08
GUDID 00842102114816 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2021-11-05
GUDID 00842102114809 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2021-11-05
GUDID 00842102114793 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2021-11-05
GUDID 00842102114786 FLEXBAR MACHINE CORPORATION	Mediflex Laparoscopic Instruments - Needle Holders	2021-11-03
GUDID 00842102114779 FLEXBAR MACHINE CORPORATION	Mediflex Laparoscopic Instruments - Needle Holders	2021-10-22
GUDID 00842102114717 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2021-10-20
GUDID 00842102114700 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2021-10-20
GUDID 00842102114687 FLEXBAR MACHINE CORPORATION	Flexarm Surgical Holders and Positioners	2021-10-20
PMN K102663 | FJL FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Reusable Electrodes	2018-12-14
PMN K102663 | FDC FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Reusable Electrodes	2018-12-14
PMN K102663 | FAS FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Reusable Electrodes	2018-12-14
PMN K081503 | GEI FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Deluxe Laparoscopic Instruments	2018-12-14
PMN K081503 | GEI FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Cutting Edge Handle with Ratchet	2018-12-14
PMN K081503 | GEI FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex 3.5mm Laparoscopic Instruments	2018-12-14
HXD FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	CLAMP	2017-05-11
PMN K954276 | HAW FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	SUGITA HEADFRAME ADAPTER	2016-10-24
PMN K102146 | KCT FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Container System	2015-04-23
GCZ FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Surgeon's Sturgeon	2014-11-19
PMN K090340 | GCJ FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Freehand	2014-06-25
PMN K930474 | GCJ FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Laparoscopic Needle Holder	2014-03-27
PMN K930474 | FHO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Laparoscopic Needle Holder	2014-03-27
HCF FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Suture Grasper Closure Device	2014-03-27
HCF FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Multi-Pupose Knot Pusher	2014-03-27
GBZ FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Cholangiography Catheter	2014-03-27
PMN K123728 | GCJ FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Laparoscopic Tissue Retrieval Bag	2013-12-18
PMN K123728 FLEXBAR MACHINE CORP.	RETRIEVAL BAG	2013-12-11
LRP FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Sterilization Container	2013-09-25
FZX FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Suture Passer Guide	2013-09-25
CCX FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Airway Assist	2013-09-05
FBM FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Portland trcars and flexible retractors	2013-06-04
NWV FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Scope Warmer	2012-04-12
NWV FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex One Piece Needle Holder	2012-04-12
NWV FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Modular Needle Holder	2012-04-12
NWV FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Clip Applier	2012-04-12
GDO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Clip Applier	2011-12-08
FDG FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Retractor, Fiberoptic	2011-12-08
PMN K103840 | GEI FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	The Cutting Edge	2011-08-24
BWN FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex StrongArm	2011-08-05
BWN FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex FlexArm	2011-08-05
PMN K103840 FLEXBAR MACHINE CORP.	CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE	2011-02-28
PMN K974382 | GCJ FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	The Cutting Edge	2009-08-25
GZT FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Davida Neurological Retractor System	2007-11-28
FFO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Universal Surgical Retractor System Medi-Flex	1995-01-23
FFO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Universal Retractor System	1995-01-23
FFO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Nathanson Liver Retractor	1995-01-23
FFO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	LAPRO-FLEX	1995-01-23
FFO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	FlexGuard Retractor Blade Cushion	1995-01-23
FFO FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Bookler Table Mounted Retractor System	1995-01-23
GAD FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	LaproFlex	1978-06-12
GAD FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	DnyaTrac Retractor Frame	1978-06-12
FSM FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	Mediflex Lap-Rack	1978-06-12
FSM FLEXBAR MACHINE CORP. [FLEXBAR MACHINE CORP., dba Mediflex]	GREENBERG INSTRUMENT HOLDER	1978-06-12

Related Finance Registrations

NCAGE Code	2R260	FLEXBAR MACHINE CORPORATION!DBA MEDIFLEX
CAGE Code	2R260	FLEXBAR MACHINE CORPORATION MEDIFLEX
S.A.M. Registration	2R260 [47644935]	FLEXBAR MACHINE CORPORATION MEDIFLEX

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091661401	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZ AUTOSTIC COMPOUND	50 PKG
2020081344890	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	INDUSTRIAL/ ENGINEERING TOOLS	2 PKG
2020080630436	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	GRANITE COLUMN WITH INSERTS SMALL GRANITE BASE . . . . .	2 PKG
2020062558416	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZ AUTOSTIC COMPOUNDS	75 PKG
2020032119621	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	INDUSTRIAL/ENGINEERING TOOLS	1 PKG
2020031637186	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	NON HAZ AUTOSTIC COMPOUNDS	50 PKG
2020030620085	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	INDUSTRIAL ENGINEERING TOOLS	3 PKG
2020020824424	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	INDUSTRIAL/ENGINEERING TOOLS	3 PKG