Izi Medical Products L L C

FDA Filings

This page includes the latest FDA filings for Izi Medical Products L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Izi Medical Products L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Neuromedex GmbH

FDA Registration(s)

• Registration Number: 1123169
• FEI Number: 1000123143
• Name: IZI MEDICAL PRODUCTS LLC
• Owner & Operator: IZI MEDICAL PRODUCTS LLC
• Contact Address: 5 Easter Court, Suite J ; Owings Mills MD 21117 US
• Official Correspondent:
  • Qiang - Cao
  • x-410-5949403-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5 Easter Ct Ste J ; Owings Mills, MD 21117 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00815212026935 Izi Medical Products, LLC	Duro-Ject Bone Cement Injection Tube	2024-10-22
GUDID 00815212026928 Izi Medical Products, LLC	KIT:BALLOON,FILLER,ACCESS,DRILL	2024-09-05
GUDID 00815212026911 Izi Medical Products, LLC	KIT:BALLOON AND BONE FILLER	2024-09-05
GUDID 10815212026895 Izi Medical Products, LLC	OsteoPearl Vertebral Balloon (15mm), 10G	2024-08-13
GUDID 00815212026904 Izi Medical Products, LLC	OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G	2024-08-13
GUDID 00815212024467 Izi Medical Products, LLC	STRYKER NAVIGATED BIOPSY NEEDLE	2024-08-07
GUDID 00815212026881 Izi Medical Products, LLC	BKP-11-12.0-15.0-A	2024-07-08
GUDID 00815212026874 Izi Medical Products, LLC	BKP-10-12.0-15.0-A	2024-07-08
GUDID 00815212026867 Izi Medical Products, LLC	MDT NAVIGATED BIOPSY, COMPATIABLE 7D	2024-03-26
GUDID 20815212026816 Izi Medical Products, LLC	ONPOINT NAVIGATION 25 BOXES	2024-03-06
GUDID 10815212026819 Izi Medical Products, LLC	ONPOINT NAVIGATION 10 BOX	2024-03-06
GUDID 00815212026850 Izi Medical Products, LLC	ONPOINT PEDICLE ACCESS NEEDLE	2024-03-06
GUDID 00815212026843 Izi Medical Products, LLC	ONPOINT SPHERZ PASSIVE MARKER-12 PACK	2024-03-06
GUDID 00815212026836 Izi Medical Products, LLC	ONPOINT SNAP SPHERZ 25PK	2024-03-06
GUDID 00815212026829 Izi Medical Products, LLC	ONPOINT NAVIGATION TRAY	2024-03-06
GUDID 00815212026812 Izi Medical Products, LLC	ONPOINT NAVIGATION KIT	2024-03-06
GUDID 00815212026805 Izi Medical Products, LLC	Osteo-site Bone Filler Kit-MV	2024-02-26
GUDID 00815212026799 Izi Medical Products, LLC	Osteo-site Bone Filler Kit-MV	2024-02-26
GUDID 00815212026782 Izi Medical Products, LLC	Osteo-site VCF Kit, Vertefix MV Cement	2024-02-26
GUDID 00815212026775 Izi Medical Products, LLC	Vertefix MV	2024-02-26
GUDID 10815212026673 Izi Medical Products, LLC	MNAV FIDUCIAL MARKERS	2023-11-24
GUDID 10815212020268 Izi Medical Products, LLC	Multi-Modality Markers	2023-11-17
GUDID 00815212026768 Izi Medical Products, LLC	BKP-11-12.0-15.0	2023-10-02
GUDID 00815212026751 Izi Medical Products, LLC	nView 638 Short Micro-Reference Clip	2023-08-04
GUDID 00815212026744 Izi Medical Products, LLC	nView 639 Long Micro-Reference Clip	2023-08-04
GUDID 00815212026713 Izi Medical Products, LLC	nView 627 Reflective Markers -14	2023-08-04
GUDID 00815212026706 Izi Medical Products, LLC	nView 603 Extra Reflective Marker	2023-08-04
GUDID 00815212026690 Izi Medical Products, LLC	nView 428 Navigated Surgical Probe 428	2023-08-04
GUDID 00815212026683 Izi Medical Products, LLC	nView 590 Sterile Navigation Kit	2023-08-04
GUDID 00815212026720 Izi Medical Products, LLC	ORTHO-KEY 2010-05-ORTHO	2023-06-14
GUDID 00815212026645 Izi Medical Products, LLC	COAX CURVED CANNULA 13G X 19CM G13053-VHC	2022-08-24
GUDID 00815212026638 Izi Medical Products, LLC	Kyphoplasty Bone Drill 11G VA11BD	2022-08-24
GUDID 00815212026652 Izi Medical Products, LLC	7D SNAP ON SPHERZ - 5 PACK	2022-08-11
GUDID 00815212026294 Izi Medical Products, LLC	DualCore Biopsy System-16g x 16cm 5pk	2022-05-30
GUDID 00815212026287 Izi Medical Products, LLC	DualCore Biopsy System-16g x 10cm 5pk	2022-05-30
GUDID 00815212026270 Izi Medical Products, LLC	DualCore Biopsy System-14g x 16cm 5pk	2022-05-30
GUDID 00815212026263 Izi Medical Products, LLC	DualCore Biopsy System-14g x 10cm 5pk	2022-05-30
GUDID 00815212026256 Izi Medical Products, LLC	DualCore Biopsy System-12g x 16cm 5pk	2022-05-30
GUDID 00815212026249 Izi Medical Products, LLC	DualCore Biopsy System-12g x 10cm 5pk	2022-05-30
GUDID 00815212026232 Izi Medical Products, LLC	DualCore Biopsy System-16g x 16cm	2022-05-30
GUDID 00815212026225 Izi Medical Products, LLC	DualCore Biopsy System-16g x 10cm	2022-05-30
GUDID 00815212026218 Izi Medical Products, LLC	DualCore Biopsy System-14g x 16cm	2022-05-30
GUDID 00815212026201 Izi Medical Products, LLC	DualCore Biopsy System-14g x 10cm	2022-05-30
GUDID 00815212026195 Izi Medical Products, LLC	DualCore Biopsy System-12g x 16cm	2022-05-30
GUDID 00815212026188 Izi Medical Products, LLC	DualCore Biopsy System-12g x 10cm	2022-05-30
GUDID 00815212026171 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-16g x 16cm 5pk	2022-05-30
GUDID 00815212026164 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-16g x 10cm 5pk	2022-05-30
GUDID 00815212026157 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-14g x 16cm 5pk	2022-05-30
GUDID 00815212026140 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-14g x 10cm 5pk	2022-05-30
GUDID 00815212026133 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-12g x 16cm 5pk	2022-05-30
GUDID 00815212026126 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-12g x 10cm 5pk	2022-05-30
GUDID 00815212026119 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-16g x 16cm	2022-05-30
GUDID 00815212026102 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-16g x 10cm	2022-05-30
GUDID 00815212026096 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-14g x 16cm	2022-05-30
GUDID 00815212026089 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-14g x 10cm	2022-05-30
GUDID 00815212026072 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-12g x 16cm	2022-05-30
GUDID 00815212026065 Izi Medical Products, LLC	DualCore Biopsy System w/Coax-12g x 10cm	2022-05-30
GUDID 00815212026409 Izi Medical Products, LLC	Arcadia Curved Delivery Cannula	2022-05-26
GUDID 00815212026386 Izi Medical Products, LLC	ACCELUS SNAP ON SPHERZ - 80 PACK	2022-05-26
GUDID 00815212026379 Izi Medical Products, LLC	ACCELUS SNAP ON SPHERZ - 4 PACK	2022-05-26
GUDID 00815212025624 Izi Medical Products, LLC	SPHERZ: ILUMARK NONSTERILE 1010-05	2022-05-26
GUDID 00815212026362 Izi Medical Products, LLC	Bone Filler Kit-HV EU	2022-05-12
GUDID 00815212026393 Izi Medical Products, LLC	Pair Rotating Luer Lock Connectors	2022-03-30
GUDID 00815212026003 Izi Medical Products, LLC	QC-20-20.0-10T	2021-10-28
GUDID 00815212025990 Izi Medical Products, LLC	QC-20-11.0-20T	2021-10-28
GUDID 00815212025983 Izi Medical Products, LLC	QC-20-11.0-10T	2021-10-28
GUDID 00815212025976 Izi Medical Products, LLC	QC-18-20.0-10T	2021-10-28
GUDID 00815212025969 Izi Medical Products, LLC	QC-18-11.0-20T	2021-10-28
GUDID 00815212025952 Izi Medical Products, LLC	QC-18-11.0-10T	2021-10-28
GUDID 00815212025945 Izi Medical Products, LLC	QC-16-20.0-10T	2021-10-28
GUDID 00815212025938 Izi Medical Products, LLC	QC-16-15.0-10T	2021-10-28
GUDID 00815212025921 Izi Medical Products, LLC	QC-16-11.0-20T	2021-10-28
GUDID 00815212025914 Izi Medical Products, LLC	QC-16-11.0-10T	2021-10-28
GUDID 00815212025907 Izi Medical Products, LLC	QC-14-9.0-10T	2021-10-28
GUDID 00815212025891 Izi Medical Products, LLC	QC-14-6.0-20T	2021-10-28
GUDID 00815212025884 Izi Medical Products, LLC	QC-14-6.0-10T	2021-10-28
GUDID 00815212025877 Izi Medical Products, LLC	QC-14-20.0-20T	2021-10-28
GUDID 00815212025860 Izi Medical Products, LLC	QC-14-20.0-10T	2021-10-28
GUDID 00815212025853 Izi Medical Products, LLC	QC-14-15.0-10T	2021-10-28
GUDID 00815212025846 Izi Medical Products, LLC	QC-14-11.0-20T	2021-10-28
GUDID 00815212025839 Izi Medical Products, LLC	QC-14-11.0-10T	2021-10-28
GUDID 00815212025822 Izi Medical Products, LLC	QCS-20-11.0-20T	2021-10-28
GUDID 00815212025815 Izi Medical Products, LLC	QCS-20-11.0-10T	2021-10-28
GUDID 00815212025808 Izi Medical Products, LLC	QCS-18-11.0-20T	2021-10-28
GUDID 00815212025792 Izi Medical Products, LLC	QCS-18-11.0-10T	2021-10-28
GUDID 00815212025785 Izi Medical Products, LLC	QCS-20-20.0-10T	2021-10-28
GUDID 00815212025778 Izi Medical Products, LLC	QCS-16-11.0-20T	2021-10-28
GUDID 00815212025761 Izi Medical Products, LLC	QCS-16-11.0-10T	2021-10-28
GUDID 00815212025754 Izi Medical Products, LLC	QCS-18-20.0-10T	2021-10-28
GUDID 00815212025747 Izi Medical Products, LLC	QCS-14-11.0-20T	2021-10-28
GUDID 00815212025730 Izi Medical Products, LLC	QCS-14-11.0-10T	2021-10-28
GUDID 00815212025723 Izi Medical Products, LLC	QCS-16-20.0-10T	2021-10-28
GUDID 00815212025716 Izi Medical Products, LLC	QCS-14-20.0-10T	2021-10-28
GUDID 00815212025709 Izi Medical Products, LLC	QCS-14-15.0-10T	2021-10-28
GUDID 00815212025693 Izi Medical Products, LLC	QCS-16-20.0-20T	2021-10-28
GUDID 00815212025686 Izi Medical Products, LLC	QCS-16-15.0-10T	2021-10-28
GUDID 00815212025679 Izi Medical Products, LLC	QCS-16-9.0-10T	2021-10-28
GUDID 00815212025662 Izi Medical Products, LLC	QCS-14-9.0-10T	2021-10-28
GUDID 00815212025655 Izi Medical Products, LLC	QCS-14-20.0-20T	2021-10-28
GUDID 00815212025648 Izi Medical Products, LLC	QCS-14-15.0-20T	2021-10-28
PMN K973565 | KNW IZI MEDICAL PRODUCTS LLC	Quick-Core Biopsy Needle	2020-01-15
MIJ IZI MEDICAL PRODUCTS LLC	Breast Lesion Localization Needle	2020-01-15
PMN K191012 | OLO IZI MEDICAL PRODUCTS LLC	Navigated Pedicle Access Kit	2019-10-30
PMN K191012 IZI Medical Products LLC	Navigated Pedicle Access Kit	2019-08-07
PMN K141141 | NDN IZI MEDICAL PRODUCTS LLC	KIVA VCF Treatment System	2018-07-27
PMN K141141 | LOD IZI MEDICAL PRODUCTS LLC	KIVA VCF Treatment System	2018-07-27
PMN K070293 | OCJ IZI MEDICAL PRODUCTS LLC	Blazer	2018-07-27
PMN K103433 | NDN IZI MEDICAL PRODUCTS LLC	VBC-200	2018-02-15
PMN K080873 | NDN IZI MEDICAL PRODUCTS LLC	VBC-300	2018-02-15
PMN K043593 | NDN IZI MEDICAL PRODUCTS LLC	VBC	2018-02-15
PMN K042691 | NDN IZI MEDICAL PRODUCTS LLC	VBC-100	2018-02-15
PMN K170008 | KNW IZI MEDICAL PRODUCTS LLC	Bone Biopsy Needles	2018-02-12
PMN K991319 | IYE IZI MEDICAL PRODUCTS LLC	IZI Thermoplastic Mask	2017-03-01
PMN K162265 | IYE IZI MEDICAL PRODUCTS LLC	CushionCast Moldable Cushion	2017-03-01
PMN K103449 | KXK IZI MEDICAL PRODUCTS LLC	IZI Gold Fiducial Markers	2017-03-01
PMN K103449 | IYE IZI MEDICAL PRODUCTS LLC	IZI Gold Fiducial Markers	2017-03-01
PMN K162265 IZI Medical Products LLC	CushionCast Moldable Cushions	2016-11-15
PMN K143241 | HAW IZI MEDICAL PRODUCTS LLC	Navigated Brain Biopsy Cannula - Compatible Medtronic	2015-08-06
PMN K143241 IZI MEDICAL PRODUCTS LLC	MDT Navigable Brain Biopsy Cannula	2015-04-13
PMN K142344 | HAW IZI MEDICAL PRODUCTS LLC	Disposable Passive Accessory	2015-03-31
PMN K142344 IZI MEDICAL PRODUCTS LLC	DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System	2015-03-20
PMN K140705 | HAW IZI MEDICAL PRODUCTS LLC	BL Navigated Biopsy Needle	2015-01-05
PMN K132124 | IYE IZI MEDICAL PRODUCTS LLC	KLARITY SHELL SYSTEM* for Klarity AccuCushions?	2015-01-05
PMN K132124 | IYE IZI MEDICAL PRODUCTS LLC	AccuCushions?	2015-01-05
PMN K022708 | IYE IZI MEDICAL PRODUCTS LLC	Thermoplastic Mask	2012-09-10
IME IZI MEDICAL PRODUCTS LLC	Cold Care Pack	2012-09-10
PMN K964972 | KPQ IZI MEDICAL PRODUCTS LLC	ShadowForm Markers	2007-11-09
PMN K022074 | HAW IZI MEDICAL PRODUCTS LLC	Spherz	2007-11-09
PMN K014022 | IYE IZI MEDICAL PRODUCTS LLC	Multi-Modality Markers	2007-11-09
FZZ IZI MEDICAL PRODUCTS LLC	Indicator Radiopaque Markers	1993-11-19
FZZ IZI MEDICAL PRODUCTS LLC	Indicator Radiolucent Markers	1993-11-19
FZZ IZI MEDICAL PRODUCTS LLC	Indicator Mammography Markers	1993-11-19

Related Finance Registrations

NCAGE Code	4DLN4	IZI MEDICAL PRODUCTS, LLC!DBA IZI MEDICAL!DIV IZI MEDICAL PRODUCTS
CAGE Code	4DLN4	IZI MEDICAL PRODUCTS, LLC IZI MEDICAL IZI MEDICAL PRODUCTS
S.A.M. Registration	4DLN4 [933506164]	IZI MEDICAL PRODUCTS, LLC IZI MEDICAL
SEC	0001461212	IZI Medical Products LLC of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082645348	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS MOLDCARE HS CODE940490	4 CTN
2020082079646	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS MOLDCARE HS CODE940490	4 CTN
2020022231308	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS CODE940490	8 CTN
2020022137293	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS CODE940490	8 CTN
2019041865474	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS CODE940490	46 CTN
2018021043942	Tokyo ,Japan -> Long Beach, California	MEDICAL INSTRUMENTS HS CODE940490	52 CTN