ClearanceBrief
Panels › Cardiovascular › Product code DXT · Class 2

Injector And Syringe, Angiographic

Regulation 870.1650

7510(k)s in 12 months (211 all time)
8recalls in 12 months (70 all time)
58recalls that name a 510(k)
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Top companies in DXT

DateFirm and productCodeLinked 510(k)
Sep 11, 2026Bayer Medical Care, Inc.
MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Open, Classified
DXTK182273
Jun 3, 2026Bayer Medical Care, Inc.
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007
Open, Classified
DXTK050456
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
Open, Classified
DXTNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
Open, Classified
DXTNone listed
Apr 17, 2026Medline Industries, LP
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP
Open, Classified
DXTNone listed
Apr 17, 2026Medline Industries, LP
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Open, Classified
DXTNone listed
Apr 7, 2026Medline Industries, LP
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/
Open, Classified
DXTK113198
Apr 7, 2026Medline Industries, LP
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medli
Open, Classified
DXTK873955
Oct 11, 2024Merit Medical Systems, Inc.
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Open, Classified
DXTK011811
Oct 11, 2024Merit Medical Systems, Inc.
IntelliSystem Inflation Device, REF: IN1525/D
Open, Classified
DXTK884913
Oct 11, 2024Merit Medical Systems, Inc.
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Open, Classified
DXTK160107
Oct 11, 2024Merit Medical Systems, Inc.
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Open, Classified
DXTK083523
Oct 11, 2024Merit Medical Systems, Inc.
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to
Open, Classified
DXTK011811
Oct 11, 2024Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30
Open, Classified
DXTK011811
Oct 11, 2024Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syring
Open, Classified
DXTK011811
Oct 11, 2024Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syri
Open, Classified
DXTK011811
Oct 11, 2024Merit Medical Systems, Inc.
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch s
Open, Classified
DXTK011811
Oct 11, 2024Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters
Open, Classified
DXTK011811
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206
Open, Classified
DXTNone listed
Nov 3, 2023B. Braun Medical, Inc.
30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
Open, Classified
DXTNone listed
Nov 3, 2023B. Braun Medical, Inc.
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
Open, Classified
DXTNone listed
Sep 14, 2021Bayer Medical Care, Inc.
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is des
Terminated
DXTK132928
Apr 6, 2021LeMaitre Vascular, Inc.
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-0
Terminated
DXTK973334
Oct 5, 2020Bayer Medical Care, Inc.
Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike
Terminated
DXTK192370
Dec 14, 2018Bayer Medical Care, Inc.
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Med
Terminated
DXTK023183
K112086 +2
Nov 12, 2018Bracco Injeneering S.A.
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and EmpowerCTA+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a steril
Terminated
DXTK933846
Aug 2, 2016Bayer Healthcare
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific pur
Terminated
DXTK082905
Jun 9, 2016Bayer Healthcare
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery
Terminated
DXTK143538
Feb 2, 2016Acist Medical Systems
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000
Terminated
DXTK052744
K984231
Sep 16, 2015Bayer Healthcare
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing
Terminated
DXTK132928
May 28, 2015Medrad Inc dba Bayer R&I
MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (C
Terminated
DXTK082905
Apr 18, 2013Acist Medical Systems
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Terminated
DXTK040298
Feb 21, 2013Medrad Inc
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to
Terminated
DXTK050456
Jul 26, 2012Mallinckrodt Inc
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposa
Terminated
DXTK781334
Feb 29, 2012Mallinckrodt Inc
Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch, with 100 pouches per case; Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Sterile, The purpos
Terminated
DXTK882329
Feb 29, 2012Mallinckrodt Inc
Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per ca
Terminated
DXTK984088
Feb 29, 2012Mallinckrodt Inc
Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas
Terminated
DXTK984088
Feb 29, 2012Mallinckrodt Inc
Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per cas
Terminated
DXTK984088
Feb 29, 2012Mallinckrodt Inc
Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case. Sterile,
Terminated
DXTK984088
Feb 29, 2012Mallinckrodt Inc
Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case. Sterile,
Terminated
DXTK984088
Jan 19, 2012Mallinckrodt Inc
Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile
Terminated
DXTK781334
Nov 2, 2011Medrad Inc
Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into
Terminated
DXTK023183
Jul 22, 2011Medrad Inc
MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions
Terminated
DXTK050456
Nov 15, 2010Medrad Inc
MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast me
Terminated
DXTNone listed
Jul 9, 2010Medrad Inc
Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
Terminated
DXTK023183
Mar 23, 2010Medrad Inc
Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
Terminated
DXTK050456
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220
Terminated
DXTK884913
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filtered Sosa spike. Used to transfer contrast or saline into a sterile injector syringe
Terminated
DXTK884913
Dec 14, 2009Merit Medical Systems, Inc.
Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC NEEDLES 20 G CATALOG NUMBER AN20T52C for the introduction of vascular access devices.
Terminated
DXTNone listed
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for inflation and deflation of interventional devices
Terminated
DXTK884913

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