FDA.reportPublic FDA data

BARD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14245263002942387BARD BRACHYTHERAPY, INC1N2026-01-01295 E. LIES RD. CAROL STREAM IL US 60188
20203942020394BARD PERIPHERAL VASCULAR, INC.1Y2026-01-011625 W 3rd St TEMPE AZ US 85281
80406073002806591BARD SDN. BHD.1N2026-01-01LOT 57-C KULIM INDUSTRIAL ESTATE KULIM Kedah MY 09000
30056365443005636544BARD SHANNON LIMITED1N2026-01-01San Geronimo Industrial Park Km. 76.7 Lot #1 Road #3 Bo. Rio Abajo Humacao PR US 00791
30062607403006260740Bard Access Systems, Inc.1Y2026-01-01605 North 5600 West Salt Lake City UT US 84116
30142267073014226707BARDY DIAGNOSTICS, INC.1N2026-01-01220 120th Avenue NE, Suite 100 Bellevue WA US 98005
30142267073014226707BARDY DIAGNOSTICS, INC.1N2020-04-25316 Occidental Ave S, Suite B310 Seattle WA US 98104

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00801741240034PowerPICC SOLO - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240041PowerPICC Provena SOLO - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240058PowerPICC Provena SOLO - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CG - Catheter Placement kit+1(800)545-0890medical.services@crbard.com
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CG - Catheter Placement kit+1(800)545-0890medical.services@crbard.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
700621548799812P860064DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KITLNY1988-02-29
360571759294480P180037Venovo Venous Stent SystemQAN2019-03-13
360571489855055P170042Covera™ Vascular Covered StentPFV2018-07-30
360571549833751P160024LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENTPRL2017-04-24
360571977743193P130029FLUENCY PLUS ENDOVASCULAR STENT GRAFTPFV2014-06-17
360571001387635P080007BARD E-LUMINEXX VASCULAR STENTNIO2008-12-04
360571319940737P070014LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEMNIP2009-02-13
360571979670699P060002FLAIR ENDOVASCULAR STENT GRAFTPFV2007-07-23
700621441992153K993848MILLENNIUM HUBER PLUS SAFETY INFUSION SETFPA2000-01-27
360571172894015K993785ULTRACLIP TISSUE MARKERGDW2000-02-04
700621066925532K993624SITE-RITE 3 ULTRASOUND SYSTEMIYO1999-11-10
700621274882415K993000BARD HYDROPHILIC COATED GUIDE WIRESDQX1999-11-02
360571406886467K991280125 IMPLANT SEEDS, MODEL STM1251KXK1999-10-20
360571453107310K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETDYB1999-06-28
700621453107310K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETDYB1999-06-28
360571282329718K983861DISTAFLO BYPASS GRAFTDSY1998-11-24
360571519549676K983769DISTAFLO BYPASS GRAFTDYF1998-12-15
700621830771178K980994IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICESFPA1998-05-29
700621543537808K980992IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICESFPA1998-05-28
360572011477985K972152DEVMED STEPPING AND STABILIZING SYSTEMITX1997-08-15
360571133990381K970099SIMON NITINOL FILTER/STRAIGHT LINE SYSTEMDTK1997-04-16
700622045943643K965178NIAGARA DUAL LUMEN CATHETERMPB1997-08-19
700621005362573K964066DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)LJT1997-03-06
360571937997433K962907SKINNY,FRANSEEN,WESCOTT NEEDLESKNW1996-10-23
360571333831824K962077BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACERKNW1996-07-30
700621365885114K955110NAVARRE PERCUTANEOUS BILIARY DRAINAGEFGE1996-11-07
700621373844132K954422PER-Q-CATH MID-LINELJS1995-12-15
700621275020994K954104PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICESLJS1995-11-21
361051395807547K953577BARD VISILEX MESH 3 X 6FTL1995-09-26
700621999107005K951907NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETERGBX1995-05-15
700621578428099K951475NAVARRE UNIVERSAL DRAINAGE CATHETERGBX1995-04-24
360661308305285K951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTKOD1995-09-27
700621338910207K946249BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBESKNT1995-12-11
700621340342360K946249BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBESKNT1995-12-11
700621145183933K943663NAVARRE 600 ML DRAINAGE BAGEXF1994-09-08
700621621571799K943038STATLOCK-IPIDURALFPA1995-04-10
700621041208174K942931STATLOCK SECUREMENT DEVICESFPA1995-03-28
360571945453137K936194COAXIAL BIOPSY NEEDLEFCG1994-03-22
360571073109029K934371BIP MULTI MODIFICATIONKNW1994-04-28
360571505165304K934370BIP BIOPSY NEEDLE MODIFICATIONFCG1994-03-07
360571164952564K930217BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLEFMI1994-02-28
700621508600562K9263313.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATHLJS1994-03-07
700621496748274K926139CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATHLJT1995-01-03
700621286340318K924250PLASTIC LOW PROFILE SUBCUTANEOUS PORTLJT1993-10-04
361051633967069K922916BARD MARLEX MESH DARTFTL1992-08-24
361051529270858K915841BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPICKNT1993-06-25
700621529270858K915841BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPICKNT1993-06-25
700621596782597K915837NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEMKNT1993-03-23
360571446799131K915801BIP-COAX-SYSTEMFCG1994-03-11
700621302568869K915167GESCO PER-Q-CATH CATHETER INTRODUCERDYB1992-01-27
700621308019307K914210VAS-CATH DUALATOR(TM) VESSEL DILATORFKA1993-07-01
700621758308979K914162VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERSLFJ1993-07-01
360571751235665K913306BONE-TEMNO/STERNUM-TEMNOLWE1991-11-01
700621953372131K912702PLASTIC ATTACHABLE DUAL PORTLJT1991-09-18
700621433732099K910622GESCO PER-Q-CATH REPAIR KITLJS1991-03-29
360571718468319K905073CARDIOVASCULAR REPAIR PATCHDXZ1991-12-20
700621405464196K904779BUTTON REPLACEMENT GASTROSTOMY DEVICEKGC1991-01-18
700621504644756K904558DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VALFOZ1991-02-11
700621347228780K903530PERCUTANEOUS INTRODUCERSDYB1990-10-22
360571748241025K903390MEDRAD MARK V-PLUS INJECTORDXT1990-09-26
700621274743694K881743VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETERLFJ1988-06-23
700621494092634K880571CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEMLJT1988-03-04
700621025498031K873213HICKMAN PLASTIC SUBCUTANEOUS PORTLJT1987-10-27
700621188913735K871998GROSHONG CV CATHETER REPAIR KITLJS1987-06-24
700621573255441K871488VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATHLFJ1987-06-12
700622073605080K871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERDQY1987-08-12
700621723960493K870260HICKMAN TITANIUM SUBCUTANEOUS PORTLJT1987-04-15
700621834748142K863606BUTTERFLY NON-CORING NEEDLE SETFMI1986-12-18
700621332671973K862127DYMAX PERSONAL SCANNERIYO1986-12-11
361051043927615K860432PERCUTANEOUS INTRODUCER KITDYB1986-03-31
700621043927615K860432PERCUTANEOUS INTRODUCER KITDYB1986-03-31
700621699051130K860256BRAWN AND GROSHONG CATHETERSFOZ1986-03-28
700621962523168K844433VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULALFJ1985-03-13
360571682969405K843083CORMED HUBER POINT NEEDLEGAA1984-09-05
700621682969405K843083CORMED HUBER POINT NEEDLEGAA1984-09-05
700621389306969K840846STERILE HICHMAN/BROVIAC INJECTION CAPLJS1984-07-06
700621271494613K831386GROSHONG CATHETER, LONG TERM TYPELJS1983-10-14
360571899218900K830471KELLY-WICK TANNELERDWS1983-03-24
361051205175991K830406NON-STERILE CATHETER REPAIR KITSLJS1983-03-01
700621205175991K830406NON-STERILE CATHETER REPAIR KITSLJS1983-03-01
700621401492422K830256NON-STERILE BROVIAC PARENTERAL ALIMI-LJS1983-03-01
700621994827074K830233NON-STERILE,SINGLE/SOUBLE LUMEN-CATHLJS1983-02-28
360571318321756K813338BIOPSY NEEDLES & TRAYSFSH1982-01-28
360571800074813K770835PATCH FABRICDXZ1977-10-05
360571849917475K770235DEBAKEY VASCULOUR-D PROSTHESESDSY1977-02-24
360571249502382K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemKNW2025-12-12
700621669991411K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortLJT2025-09-05
360571232733940K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)GEI2025-08-19
700621530813651K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortLJT2025-06-18
360571113812612K250068Venclose digiRF Generator (VCRFG1)GEI2025-02-04
360571989753253K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitKNW2025-07-10
360571339592358K243642UltraCor™ Twirl™ Breast Tissue MarkerNEU2025-03-24
360571398370702K242757Rotarex Atherectomy SystemMCW2025-01-30
700621589503568K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemSEF2025-04-09
700621189516440K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsLJT2024-10-31
360571594700444K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-PNG2024-12-06
700621290846865K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetPTI2024-11-27
700621751532459K240359PowerGlide Pro™ Midline CatheterFOZ2024-07-29
360571414125310K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitDTK2024-02-29
700621247749627K240146BD Prevue™ II Peripheral Vascular Access SystemIYO2024-02-18
3013471983962589K233110Carnation Ambulatory MonitorDSH2023-11-22
700621887013443K233106AccuCath Ace™ Intravascular CatheterFOZ2024-04-19
700621810320456K231283SiteRite™ 9 Ultrasound SystemIYO2023-09-11
360572018243015K230356Aspirex™ Thrombectomy SystemQEW2023-03-31
700621087250660K223198BD Intraosseous Vascular Access System EMS Powered Driver (D001003)MHC2022-11-10
360571178139770K223177Highlander™ 014 PTA Balloon Dilatation CatheterLIT2023-01-20
360571916396666K222793WavelinQ™ GeneratorGEI2022-10-17
700621140095247K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyLJS2022-08-24
360571437386442K221440Liverty™ TIPS Access SetDYB2022-05-31
360571323411502K220270Aspirex Thrombectomy SystemQEW2022-06-21
360571132978604K213896BD Trek Powered Bone Biopsy SystemKNW2022-03-30
700621086868116K213203Provena(TM) Midline CatheterPND2022-05-13
360571306025844K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty CatheterDQY2022-05-04
360571577739406K211933EleVation Breast Biopsy SystemKNW2021-07-15
360571522886931K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven CatheterGEI2021-08-03
360572035653455K211738Rotarex Atherectomy SystemMCW2021-09-14
360571809796878K211410GlidePath 13F Long-Term Hemodialysis CatheterMSD2021-06-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJS512022-08-24
MSD332021-07-01
KNW232025-12-12
LJT232025-09-05
FOZ182024-07-29
FPA142016-08-18
DYB132022-05-31
KXK122014-05-02
IYO112024-02-18
NEU102025-03-24
DQY102022-05-04
GEI92025-08-19
LIT92023-01-20
FTL92012-11-02
KNT92010-12-22
MPB62017-04-04
FGE62013-08-30
ITX52017-05-22
NFK52010-07-29
DSY52005-09-20
LFJ51993-07-01
DSH42023-11-22
PND42022-05-13
FMI42019-11-13
PFV42018-07-30
MCW32025-01-30
PNG32024-12-06
DTK32024-02-29
PDU32021-08-12
PQK32019-10-17
OZT32017-12-13
GDW32015-03-09
OTP32009-01-15
FCG31994-03-22
PTI22024-11-27
QEW22023-03-31
MHC22022-11-10
PTD22019-08-02
PNO22017-09-22
NIE22015-06-01

PMA#

Venovo™ Venous Stent System

2023-02-02

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS012 Date Received01/06/2023 Decision Date02/02/2023 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

LifeStent™ 5F Vascular Stent Systems

2023-02-02

BARD PERIPHERAL VASCULAR, INC.1415 West 3rd St.tempe, AZ 85281 PMA NumberP070014 Supplement NumberS064 Date Received01/06/2023 Decision Date02/02/2023 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

LifeStream® Balloon Expandable Vascular Covered Stent

2022-08-23

BARD PERIPHERAL VASCULAR, INC.1625 West 3rd St.tempe, AZ 85281-1740 PMA NumberP160024 Supplement NumberS012 Date Received02/24/2022 Decision Date08/23/2022 Product Code PRL  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee S...

Bard E- Luminexx Vascular Stent System

2022-05-26

BARD PERIPHERAL VASCULAR, INC.1415 West 3rd St.tempe, AZ 85281 PMA NumberP080007 Supplement NumberS027 Date Received05/02/2022 Decision Date05/26/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Venovo Venous Stent System

2022-05-23

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS011 Date Received05/19/2022 Decision Date05/23/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

Venovo Venous Stent System

2022-05-20

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS010 Date Received04/26/2022 Decision Date05/20/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

Venovo Venous Stent System

2022-04-22

Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS009 Date Received03/25/2022 Decision Date04/22/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

159 records. Showing 1-40. Next

PMN#

87 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next