Stat Medical Devices Inc

FDA Filings

This page includes the latest FDA filings for Stat Medical Devices Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1058955
• FEI Number: 1000525253
• Name: STAT MEDICAL DEVICES, INC.
• Owner & Operator: STAT MEDICAL DEVICES, INC.
• Contact Address: 2056 NE 153rd Street --; North Miami Beach FL 33162 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2056 NE 153rd St ; North Miami Beach, FL 33162 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 40709334761882 Stat Medical Devices, Inc.	STAT Medical Devices RQN-100	2024-01-12
GUDID 50709334581210 Stat Medical Devices, Inc.	STAT Medical Devices BTM-100	2023-12-06
GUDID 30709334883884 Stat Medical Devices, Inc.	STAT Medical Devices RQL-100	2023-12-06
GUDID 00709334980001 Stat Medical Devices, Inc.	STAT Medical Devices SM-QLL-L02	2023-12-06
GUDID 00709334992004 Stat Medical Devices, Inc.	STAT Medical Devices SM-TLD-L02	2023-11-24
PMN K092016 | FMI STAT MEDICAL DEVICES, INC.	STAT Super-Fine Insulin Pen Needle Xtra	2009-11-16
PMN K092016 | FMI STAT MEDICAL DEVICES, INC.	STAT Super-Fine Insulin Pen Needle Standard	2009-11-16
PMN K092016 | FMI STAT MEDICAL DEVICES, INC.	STAT Super-Fine Insulin Pen Needle Micro	2009-11-16
PMN K092016 STAT MEDICAL DEVICES, INC.	SUPER-FINE PEN NEEDLE	2009-10-02
FMK STAT MEDICAL DEVICES, INC.	Wellion Lancing Device	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	ULTIMATE Lancing Device	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	TRIO Lancing Device	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Sure Flex Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let Comfort Thins Xtra Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let Comfort Thins Twist-Off 28g Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let Comfort Thins Micro Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let Comfort Thins Macro Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let COmfort Thins Ultra Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let AUTO Clinical Safety Lancet Tender	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let AUTO Clinical Safety Lancet Pediatric	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let AUTO Clinical Safety Lancet Normal	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let AUTO Clinical Safety Lancet Neonatal/Heelstick	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let AUTO Clinical Safety Lancet Lite	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Stat-Let AUTO Clinical Safety Lancet Comfort	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Safe-Let Lanceta Automatica De Seguranca Comfort	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT QWIK-LANCE	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet XTRA	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet Tender	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet Pediatric	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet Normal	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet Neonatal/Heelstick	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet Lite	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet HIGH-FLOW	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet Extended	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	STAT AUTO Clinical Safety Lancet Comfort	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Restorative Solutions Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	QWIK-LANCE Clinical Safety Lancet	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	ProfiLine Clinical Safety Lancets Normal Depth	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	ONE DROP Lancing Device	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	ONE DROP Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Nipro Lite Shot Slim Lancing Device	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	LITE Lancing Device	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Glucertain Clinical Safety Lancets 28 gauge	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Glucertain Clinical Safety Lancets 26 gauge	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Comfort Thins Xtra Sterile Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Comfort Thins Ultra Sterile Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Comfort Thins Twist-Off 28g Sterile Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Comfort Thins Micro Sterile Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Comfort Thins Macro Sterile Lancets	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	CoaguSense Lancet Auto Clinical Safety Lancet 21g X 2.4mm de	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	CoaguSense Lancet Auto Clinical Safety Lancet 21g X 1.8mm de	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	BGStar Ultimate Kit	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	BGStar Lancets 33g	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	BGStar Lancets 28g	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Agamatrix ULTRA-THIN Lancets 33g	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Agamatrix ULTRA-THIN Lancets 28g	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Agamatrix Lancets 33g	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	Agamatrix Lancets 28g	1995-04-28
FMK STAT MEDICAL DEVICES, INC.	AUTO II Clinical Lancet	1995-04-28

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200222824	Pusan,South Korea -> Miami, Florida	LANCETS "SHIPMENT CONTAINS NO SOLID WOOD PACK ND LIABLE	1000 CTN
2019091262076	Pusan,South Korea -> Miami, Florida	LANCETS "SHIPMENT CONTAINS NO SOLID WOOD PACK ND LIABLE .	1218 CTN
2019090562477	Pusan,South Korea -> Miami, Florida	LANCETS "SHIPMENT CONTAINS NO SOLID WOOD PACK ND LIABLE .	1218 CTN
2019090490565	Pusan,South Korea -> Miami, Florida	LANCETS "SHIPMENT CONTAINS NO SOLID WOOD PACK ND LIABLE .	1218 CTN
2019083069102	Pusan,South Korea -> Miami, Florida	LANCETS "SHIPMENT CONTAINS NO SOLID WOOD PACK ND LIABLE .	1218 CTN
2019082982319	Pusan,South Korea -> Miami, Florida	LANCETS "SHIPMENT CONTAINS NO SOLID WOOD PACK ND LIABLE .	1218 CTN
201908223302	Hong Kong,Hong Kong -> Miami, Florida	40 CTNS PACKED INTO 2 PALLETS PLASTIC PART FO .	40 CTN
201903016018	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	LANCETS "SHIPMENT CONTAINS NO SOLID WOOD PACK ND LIABLE	200 CTN