Atrion Corp

FDA Filings

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

USA

NASDAQ

ATRI

DUNS 119202877

FDA Registration(s)

• Registration Number: 1043729
• FEI Number: 1043729
• Name: ATRION MEDICAL PRODUCTS, INC.
• Owner & Operator: ATRION CORP.
• Contact Address: ONE ALLENTOWN PKWY. --; Allen TX 75002 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1426 CURT FRANCIS RD. ; ARAB, AL 35016 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 1649914
• FEI Number: 3001665800
• Name: QUEST MEDICAL, INC.
• Owner & Operator: ATRION CORP.
• Contact Address: ONE ALLENTOWN PKWY. --; Allen TX 75002 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1 Allentown Pkwy ; ALLEN, TX 75002 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 1000324175
• FEI Number: 1000324175
• Name: Halkey-Roberts Corporation
• Owner & Operator: ATRION CORP.
• Contact Address: ONE ALLENTOWN PKWY. --; Allen TX 75002 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2700 Halkey-Roberts Place North ; Saint Petersburg, FL 33716 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PUK QUEST MEDICAL, INC. [ATRION CORP.]	Qlinch Securement Band	2020-04-06
PMN K182442 | MJJ QUEST MEDICAL, INC. [ATRION CORP.]	MiniGuard Arterial Safety Valve	2018-11-07
PMN K173716 | DTR QUEST MEDICAL, INC. [ATRION CORP.]	MPS2 Myocardial Protection System	2018-11-01
HNQ QUEST MEDICAL, INC. [ATRION CORP.]	Crawford Hook; Dandy Nerve Hook	2018-06-12
PTM ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Edwards Inflation Device REF 96417	2018-01-09
PTM ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Edwards Inflation Device REF 96402	2018-01-09
PMN K162304 | FPK QUEST MEDICAL, INC. [ATRION CORP.]	Q2? Multiport IV Administration Sets and Extension Sets	2017-10-17
PMN K162304 | FPK QUEST MEDICAL, INC. [ATRION CORP.]	Exoflex IV Extension Sets	2017-10-17
PMN K162304 | FPK QUEST MEDICAL, INC. [ATRION CORP.]	Checkmate? IV Administration Sets and Extension Sets	2017-10-17
PMN K162304 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Q2? Multiport IV Administration Sets and Extension Sets	2017-10-17
PMN K162304 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Exoflex IV Extension Sets	2017-10-17
PMN K162304 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Checkmate? IV Administration Sets and Extension Sets	2017-10-17
PMN K151079 | FPK QUEST MEDICAL, INC. [ATRION CORP.]	Q2? Multiport IV Administration Sets and Extension Sets	2017-10-17
PMN K151079 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Q2? Multiport IV Administration Sets and Extension Sets	2017-10-17
PMN K162804 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Q2 Low Pressure Power Injection Extension Set	2017-03-24
PMN K162804 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Q2 IV Extension Set	2017-03-24
PMN K113867 | OKS QUEST MEDICAL, INC. [ATRION CORP.]	LacriCATH Lacrimal Duct Catheters, Models LDC213T, LDC315T, LDC508T	2012-11-14
PMN K113118 | OKS QUEST MEDICAL, INC. [ATRION CORP.]	STENTube Lacrimal Intubation Set Model LIS052	2012-11-14
PMN K002366 | KRL QUEST MEDICAL, INC. [ATRION CORP.]	MPS Backup System (MPBUS)	2009-06-30
PMN K002366 | DXS QUEST MEDICAL, INC. [ATRION CORP.]	MPS Backup System (MPBUS)	2009-06-30
PMN K002366 | DWF QUEST MEDICAL, INC. [ATRION CORP.]	MPS Backup System (MPBUS)	2009-06-30
PMN K002366 | DTR QUEST MEDICAL, INC. [ATRION CORP.]	MPS Backup System (MPBUS)	2009-06-30
PMN K002366 | DRS QUEST MEDICAL, INC. [ATRION CORP.]	MPS Backup System (MPBUS)	2009-06-30
PMN K935233 | OKS QUEST MEDICAL, INC. [ATRION CORP.]	LacriCath	2009-05-19
PMN K922356 | MJJ QUEST MEDICAL, INC. [ATRION CORP.]	Retroguard Arterial Safety Valve	2009-05-19
PMN K061143 | FMG Halkey-Roberts Corporation [ATRION CORP.]	Robertsite 4 Way Stopcock	2008-01-25
PMN K972964 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Inflation Device	2007-11-19
PMN K972964 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL 1020 Inflation Device	2007-11-19
PMN K972964 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1015, QL1030;	2007-11-19
PMN K972964 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	AQL1015 Inflation Device	2007-11-19
PMN K972964 | HNW ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Inflation Device	2007-11-19
PMN K972964 | HNW ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL 1020 Inflation Device	2007-11-19
PMN K972964 | HNW ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1015, QL1030;	2007-11-19
PMN K972964 | HNW ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	AQL1015 Inflation Device	2007-11-19
PMN K971928 | DWF QUEST MEDICAL, INC. [ATRION CORP.]	VCC	2007-11-19
PMN K962611 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Inflation Device	2007-11-19
PMN K962611 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL 1015 Inflation Device; QL 1020 Inflation Device	2007-11-19
PMN K962611 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1030;	2007-11-19
PMN K953838 | DTR QUEST MEDICAL, INC. [ATRION CORP.]	MPS Myocardial Protection System	2007-11-19
PMN K953522 | MAV ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL2015, QL2030, QL2025T;	2007-11-19
PMN K952531 | DTL QUEST MEDICAL, INC. [ATRION CORP.]	CPS	2007-11-19
PMN K951182 | LRX ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion Contact Lens Case; 10670, Disposable SxS Lens Case	2007-11-19
PMN K951181 | LRX ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion Plus Contact Lens Case; Atrion 620 SxS Case	2007-11-19
PMN K950814 | DWF QUEST MEDICAL, INC. [ATRION CORP.]	ACC	2007-11-19
PMN K943921 | LRX ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion Plus Contact Lens Case; Atrion 620 SxS Case	2007-11-19
PMN K800825 | FPK QUEST MEDICAL, INC. [ATRION CORP.]	Q2 T-extension set	2007-11-19
PMN K790346 | JBP QUEST MEDICAL, INC. [ATRION CORP.]	ACTester /ACTest System	2007-11-19
PMN K060643 | MAV ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Series Locking Syringes	2007-11-19
PMN K060643 | MAV ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Locking Syringe	2007-11-19
PMN K060643 | MAV ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Edwards Locking Syringe REF 96406	2007-11-19
PMN K043249 | FMI ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	NeedleVISE; Atrion Large Bore Sharps Securing Device;	2007-11-19
PMN K043249 | FMI ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	NeedleVISE, Single Port	2007-11-19
PMN K041979 | DTR QUEST MEDICAL, INC. [ATRION CORP.]	Myocardial Protection System (MPS) 2	2007-11-19
PMN K041158 | CAZ ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	NeedleVISE, 5 Port	2007-11-19
PMN K041158 | CAZ ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	NeedleVISE Sharps Securing System	2007-11-19
PMN K040385 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Multiport	2007-11-19
PMN K040385 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Checkmate	2007-11-19
PMN K032840 | MAV ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Inflation Device	2007-11-19
PMN K032840 | MAV ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion QL2525, QL Series Inflation Devices,	2007-11-19
PMN K032840 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Inflation Device	2007-11-19
PMN K032840 | KOE ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion QL2525, QL Series Inflation Devices,	2007-11-19
PMN K020333 | DXT ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Series Fluid Dispensing Syringes	2007-11-19
PMN K020333 | DXT ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	QL Fluid Dispensing Syringe	2007-11-19
PMN K020333 | DXT ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion QL Fluid Dispensing Syringe;	2007-11-19
PMN K002689 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Robersite (Registered) Needlefree Injection Site Valve	2007-11-19
PMN K002689 | FPA QUEST MEDICAL, INC. [ATRION CORP.]	Q-Flex, Q2	2007-11-19
PMN K002689 | FPA Halkey-Roberts Corporation [ATRION CORP.]	Robersite (Registered) Needlefree Injection Site Valve	2007-11-19
PMN K002689 | FPA Halkey-Roberts Corporation [ATRION CORP.]	Q-Flex, Q2	2007-11-19
PMN K040634 | LHI Halkey-Roberts Corporation [ATRION CORP.]	Q2 VIAL ADAPTER	2006-01-20
HNL QUEST MEDICAL, INC. [ATRION CORP.]	Lacrimal Intubation Set, Crawford Type	2003-05-14
GAE QUEST MEDICAL, INC. [ATRION CORP.]	RETRACT-O-TAPE(R) VASCULAR LOOPS	2003-05-14
DWS QUEST MEDICAL, INC. [ATRION CORP.]	CleanCut; PerfectCut	2003-05-14
DWS QUEST MEDICAL, INC. [ATRION CORP.]	AORTIC PUNCH	2003-05-14
DWS ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	CleanCut; PerfectCut	2003-05-14
DWS ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	AORTIC PUNCH	2003-05-14
FQH ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	MISTER	2003-01-27
HNW QUEST MEDICAL, INC. [ATRION CORP.]	LACRICATH	2002-07-26
HNW QUEST MEDICAL, INC. [ATRION CORP.]	LACRICATH LACRIMAL DUCT CATHETER	2002-07-26
FOX QUEST MEDICAL, INC. [ATRION CORP.]	STAND	2001-04-11
FOX QUEST MEDICAL, INC. [ATRION CORP.]	INFUSION	2001-04-11
PMN K864503 | DWD QUEST MEDICAL, INC. [ATRION CORP.]	VRV	2000-06-12
PMN K864503 | DWD QUEST MEDICAL, INC. [ATRION CORP.]	RLV VALVES	2000-06-12
PMN K760894 | DWD QUEST MEDICAL, INC. [ATRION CORP.]	VRV	2000-06-12
PMN K760894 | DWD QUEST MEDICAL, INC. [ATRION CORP.]	RLV VALVES	2000-06-12
EHZ ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	Atrion Medical Autogenous Tissue Collector	1997-07-07
EHZ ATRION MEDICAL PRODUCTS, INC. [ATRION CORP.]	ATRION MEDICAL AUTOGE	1997-07-07

Related Finance Registrations

NCAGE Code	4Y628	ATRION CORP
CAGE Code	4Y628	ATRION CORP
SEC	0000701288	ATRION CORP of DELAWARE