Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

GERMANY

9681442

2024

stents, drains and dilators for the biliary ducts - FLEXXUS Endoscopic Biliary Stent

Complaint File Establishment

stents, drains and dilators for the biliary ducts - LifeStent Biliary Stent System; Lifestent XL Biliary Stent System

Manufacturer

stents, drains and dilators for the biliary ducts - LifeStent Biliary Stent System; LifeStent XL Biliary Stent System

Manufacturer

stents, drains and dilators for the biliary ducts - E-LUMINEXX Biliary Stent System

Manufacturer

stent, iliac - E-Luminexx Vascular Stent System; LifeStar Vascular Stent System

Manufacturer

Show all 13 Listings for ANGIOMED GMBH & CO. MEDIZINTECHNIK KG GERMANY

Bard Access Systems, Inc.

UT/USA

3006260740

2024

transducer, ultrasonic, diagnostic

Specification Developer

catheter, subclavian

Complaint File Establishment

dilator, vessel - Dilators; Dualator

Specification Developer

introducer, catheter

Specification Developer

introducer, catheter - Percutaneous Introducer Kit

Specification Developer

Show all 225 Listings for Bard Access Systems, Inc. UT/USA

BARD BRACHYTHERAPY, INC

IL/USA

1424526

2024

source, brachytherapy, radionuclide - Palladium-103 Seed Implant Kits; QuickLink Delivery System; ReadyLink Delivery System

Manufacturer

source, brachytherapy, radionuclide - Seedlinks; SourceLink Connectors; SourceLink Spacers

Manufacturer

source, brachytherapy, radionuclide - BrachySource Seed Implants; QuickLink Delivery System; ReadyLink Delivery System

Manufacturer

source, brachytherapy, radionuclide - Brachysource Seed Implants with Sourcecap Bioabsorbable Caps

Manufacturer

system, applicator, radionuclide, manual - BrachyStar Brachytherapy Needles; BrachyStar Needles; brachytherapy seed implant needles; QuickLink Loader; QuickLink Relay System; SourceLink Loader

Manufacturer; Specification Developer

Bard European Distribution Center NV

BELGIUM

3002504068

2024

stent, iliac - E-Luminexx Vascular Stent System; LifeStar Vascular Stent System

Foreign Exporter

stents, drains and dilators for the biliary ducts - LifeStent Biliary Stent System; LifeStent XL Biliary Stent System

Foreign Exporter

system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment - Fluency Plus Endovascular Stent Graft

Foreign Exporter

dislodger, stone, basket, ureteral, metal

Foreign Exporter

stents, drains and dilators for the biliary ducts - LifeStent Biliary Stent System; Lifestent XL Biliary Stent System

Foreign Exporter

Show all 19 Listings for Bard European Distribution Center NV BELGIUM

BARD PERIPHERAL VASCULAR, INC.

AZ/USA

2020394

2024

sterilization wrap containers, trays, cassettes & other accessories - Arteriovenous (AV) Sheath Tunneler Sterilization Cassette; Peripheral Vascular (PV) Sheath; Tunneler Sterilization Cassette

Manufacturer; Specification Developer

bag, polymeric mesh, pacemaker - Bard Parsonnet Pulse Generator; Pouch (Small, Large, X-Large)

Specification Developer

guide, needle, surgical - Blunt-Tip Stiffening Cannula; Chesbrough Breast Localization Wire; DuaLok Breast Lesion Localization Wire; Fixt Suturing Device; Ghiatas Beaded Breast Localization Wire; Needle Guide for Lorad Stereoguide System; UltraWire One-Handed Breast Localization Device

Specification Developer

prosthesis, vascular graft, of 6mm and greater diameter - Dynaflo Bypass Grafts

Manufacturer; Specification Developer

prosthesis, vascular graft, of less then 6mm diameter - Distaflo Bypass Graft

Manufacturer; Specification Developer

Show all 157 Listings for BARD PERIPHERAL VASCULAR, INC. AZ/USA

BARD REYNOSA S.A. DE C.V.

MEXICO

9617592

2024

biopsy needle - Magnum Core Biopsy Needles

Repackager/Relabeler

catheter, intravascular, therapeutic, long-term greater than 30 days

Contract Manufacturer; Repackager/Relabeler

set, administration, intravascular - Titanium PowerPort isp

Contract Manufacturer

port & catheter, implanted, subcutaneous, intravascular - Titanium PowerPort isp

Contract Manufacturer

port & catheter, implanted, subcutaneous, intravascular

Contract Manufacturer

Show all 167 Listings for BARD REYNOSA S.A. DE C.V. MEXICO

BARD SDN. BHD.

MALAYSIA

8040607

2024

catheter, coude - Bard Lubricath Foley Catheter; Bardex Councill Model Foley Catheter Percutaneous Nephrostomy; Bardex Nephrostomy Short Tip Councill Model Foley Catheter with Heyman Stylet; Bardia Foley Catheter; Latex Foley Catheter & Drains; Lubricath Foley Catheter (offered in strips and trays)

Contract Manufacturer

catheter, urological - Interglide-Hydrophilic Intermittent; Urinary Catheter

Contract Manufacturer

catheter, urological - Bard Lubricath Foley Catheter; Bardia Foley Catheter; Latex Foley Catheter with 30cc; Preformed Balloon

Contract Manufacturer

catheter, urological (antimicrobial) and accessories - & Foley Tray (I.C.); Bardex I.C. Foley Catheter (offered in strips and trays); Hydrogel/Silver-Coated Foley Cath

Contract Manufacturer

catheter, urological - Bard Urethral Catheterization Tray; Touchless Clean Cath

Contract Manufacturer

Show all 20 Listings for BARD SDN. BHD. MALAYSIA

BARD SHANNON LIMITED

PR/USA

3005636544

2024

introducer, catheter - Percutaneous Introducer Kit

Contract Manufacturer

mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed - Avaulta Plus Biosynthetic Support; Avualta Solo Synthetic Support

Contract Manufacturer

mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed - Avaulta Plus Biosynthetic Support; Avualta Solo Synthetic Support

Contract Manufacturer

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator - Align Urethral Support System

Contract Manufacturer

mesh, surgical, polymeric - Composix

Contract Manufacturer

Show all 98 Listings for BARD SHANNON LIMITED PR/USA

C.R. BARD, INC.

GA/USA

3006082230

2024

apparatus, autotransfusion - SureTrans

Contract Sterilizer

apparatus, autotransfusion - SureTrans

Contract Sterilizer

patch, pledget and intracardiac, petp, ptfe, polypropylene - Bard Sauvage Filamentous Fabric

Contract Sterilizer

patch, pledget and intracardiac, petp, ptfe, polypropylene - ePTFE Cardiovascular Patch

Contract Sterilizer

bag, bile collecting

Contract Sterilizer

Show all 442 Listings for C.R. BARD, INC. GA/USA

C.R. BARD, INC.

GA/USA

1018233

2024

catheter, ureteral, gastro-urology - Bard Flexible Tip Ureteral Catheter; Bard Polyurethane Urethral Catheter; Bard TigerTail Ureteral Catheter; TigerTail Flexible Tip Ureteral Cat

Contract Sterilizer; Specification Developer

uroflowmeter - 4-CHANNEL MONITOR WITH UROFLOW

Contract Sterilizer; Specification Developer

device, cystometric, hydraulic - BARD URODYNAMIC CATHETER

Contract Sterilizer; Specification Developer

patch, pledget and intracardiac, petp, ptfe, polypropylene - ePTFE Cardiovascular Patch

Contract Sterilizer

bag, bile collecting

Contract Sterilizer

Show all 472 Listings for C.R. BARD, INC. GA/USA

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Establishment Registration & Device Listing

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