FDA.reportPublic FDA data

Teleflex LLC (NADC)

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30100415113010041511Teleflex LLC (NADC)1Y2026-01-0111245 N Distribution Cove Olive Branch MS US 38654

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1522691871973463K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERDSP2000-02-18
1522691815496054K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
1522691825344893K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
1522691622323101K993157HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240FZP1999-12-17
1522691890295485K992904MINI-PORTGBW1999-10-05
1522691082195805K992664TFX MEDICAL STYLET CATHETERDRB2000-04-13
1522691800988254K992174PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMPDXC2000-03-23
1522691714885411K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-09-03
1522691188029990K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
1522691058369042K991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-06-22
1522691839921168K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65MCW1999-05-04
1522691681808333K990561OPTICAL FORCEPSJEK1999-05-14
1522691503223288K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
1522691373752975K982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250CAC1998-12-18
1522691802383666K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPSFZP1998-08-10
1522691324269584K982128SHIKANI-FRENCH SPEAKING VALVEJOH1998-10-23
1522692046232688K980987BECTON DICKINSON SYRINGEFMF1998-06-11
1522691171224525K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
1522691917104539K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETDYB1998-02-13
1522692048243536K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
1522691132793575K964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGCAC1996-12-31
1522691555305704K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMCAC1997-04-22
1522691978717364K963779RUSCH ENTERAL FEEDING TUBEFPD1997-05-23
1522691451344500K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
1522691259168468K963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)CAC1996-11-08
1522691256891744K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRKDQ1996-08-28
1522691192437532K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
1522691103997166K960883INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8GCJ1996-03-20
1522691892579738K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERLDF1996-10-17
1522691815044847K953746ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SETFPA1996-01-26
1522691768576597K952573RUSCH URODYNAMIC RECTAL BALLOON CATHETERFEN1995-06-15
1522691331050915K952100RUSCH ENDOTRACHEAL TUBE STYLETBSR1995-08-08
1522692061591535K950965KARL STORZ STENT APPLICATOR FORCEPSEOQ1995-03-31
1522691238927846K944552PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIPFZP1994-11-07
1522691427393252K943719VISISTAT STAPLERGDT1994-08-24
1522691214794697K942986ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)HGI1995-03-21
1522691764630226K942757ASHERMAN CHEST BANDAGEMGP1994-08-01
1522691589976487K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
1522691968493552K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONSKNT1994-09-28
1522691760643610K931644GERTIE MARX NEEDLEBSP1993-09-22
1522692006827772K93133816 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)HGI1994-02-16
1522691695476545K930740SURGICAL SUTURE, NONABSORABLE STAINLESS STEELGAQ1994-07-26
1522691187210249K930739SUTURES POLYPROP., POLYETHELINE, NYLON & SILKGAP1994-07-26
1522691073682262K930738SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCGAL1994-07-26
1522691644996377K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
1522691222861158K925559BILIARY STONE DISLODGERLQR1992-12-17
1522691952550559K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
1522691653367936K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
1522691369981882K924337PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYSGCX1993-07-28
1522692029440637K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
1522691397618232K920167NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KELHBI1992-03-23
1522691937999169K913302DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIEDGDY1992-07-23
1522691552258888K911915HEMOCLIP IIFZP1992-01-09
1522692006309410K911905DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIEDGAW1991-07-02
1522691386767489K911656PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYSTCAC1991-08-13
1522691291809223K911260ATRAUMATIC STANDARD SPROTTE NEEDLEBSP1991-10-21
1522691176245811K911100MEHIGAN-PILLING PHLEBETOME TMMGZ1991-06-21
1522691637234313K905768PLEUR-EVAC CHEST DRAINAGE SYSTEMSKDQ1991-02-11
1522691185328906K904507PILLING BRUSH VALVULOTOMEDWQ1991-03-01
1522691120134312K904021PNEUMOTHORAX KIT, MODIFICATIONJDC1990-10-09
1522691613763593K903643DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTUREGAW1990-12-24
1522691790377422K902327EMBOLECTOMY CATHETERDXE1991-02-25
1522691741841267K901303HORIZON SURGICAL LIGATING AND MARKING CLIPDSS1990-06-05
1522691557359422K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1990-07-24
1522691276926141K896697PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAIKDQ1990-02-08
1522691598365700K895579POLYSORB SYNTHETIC ABSORBABLE SUTUREGAN1990-07-05
1522691357585882K895516CAVITY DRAINAGE CATHETERIZATION SET, CS-01600GBX1989-12-27
1522691273091697K895417ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITLFJ1990-01-03
1522691233501069K892915PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTIONKDQ1989-06-21
1522691679534835K891371GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFGKNT1989-08-03
1522691045928769K890431PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAINGCX1989-04-04
1522691124043892K890129PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEMGCX1989-04-10
1522691027434373K884552CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETERCAZ1989-03-14
1522691624352809K884490INTRODUCER SAFETY SYRINGEDQX1989-01-17
1522692037780789K883905ARROW PNEUMOTHORAX KIT, AK-01500JOL1989-01-19
1522691745713716K882223PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYSTKDQ1988-08-16
1522691168081307K881413ELECTRO-CAUTERY SUCTION TUBEGEI1988-04-21
1522691864631712K881252PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGEGCX1988-06-17
1522691917357233K874242JEHLE CORONARY PERFUSION CATHETERSKRA1987-12-07
1522691929358858K874063ENTERON ABDOMINAL PARACENTESIS TRAYKDD1987-12-04
1522691024395737K874062ENTERON LIVER BIOPSY TRAYKNW1987-12-31
1522691000973276K873728DEKNATEL TEMPORARY CARDIAC PACING WIRELDF1987-11-03
1522691211470353K873525DEKNATEL TROCAR CATHETERJOL1987-11-02
1522691439210246K873517DEKNATEL THORACIC CATHETERJOL1987-11-02
1522691963521067K870572ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KITJOL1987-05-26
1522691461609960K862153ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLEFOZ1986-12-11
1522691048634347K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPDQY1986-08-25
1522691548878880K861924MICRO ANASTOMOSIS CLAMPDXC1986-06-06
1522691105396253K854137ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & ECDQY1985-12-03
1522691514439363K851251AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200FZP1985-07-02
1522691731648867K851140TELEFLEX MEDICAL INTRODUCER NEEDLEDWS1985-06-19
1522691493159968K843263ARROW-JOHANS ECG ADAPTORDQY1984-09-20
1522691991985150K841549HEMOCLIP AUTOMATIC CLIPS MEDIUMFZP1984-08-14
1522691638861179K841548HEMOCLIP LIGATING CLIPS M/LARGEFZP1984-08-14
1522691469220903K841547HEMOCLIP LIGATING CLIPS MED/SMLFZP1984-08-14
1522691349127718K840455EMERGENCY INFUSION DEVICEDYB1984-05-23
1522691881335972K831240LASER BRONCHOSCOPEEOQ1983-07-26
1522691246870887K823755BICEPS ELECTROCAUTERY SYSTEMHAM1983-01-26
1522691681029626K822502DISPOSABLE THERMOMETERSFLK1982-09-24
1522692051555608K820648ARROW M.I.S. MULTI-LUMEN CATHETERIZADQY1982-04-14
1522691278500972K820009ARROW JUGULAR PUNCTURE KIT 16 GA.DQY1982-01-22
1522691391255396K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
1522691734412728K811627ARROW PERITONEAL LAVAGE CATHERIZATION KGBW1981-08-10
1522691317270126K810962ARROW VESSEL CATHETER. KIT W/20GA INDWELDQY1981-04-29
1522691467755993K810675ARROW RADIAL ARTERY CATHETERIZATION SETDQX1981-03-27
1522691523401513K810391VOGLER HYSTERECTOMY FORCEPS (SMALL & LG)HCZ1981-03-04
1522691159012294K803086MYOWIRE-ATEMPORARY CARDIAC PACING WIRELDF1981-07-01
1522691631487058K802367ARROW CATHETER CLAMPKGZ1980-10-23
1522691901206440K801912ARROW POSITIVE PLACEMENT CON/EPIDURAL ANCAZ1980-09-16
1522691043319868K800079HEMOCLIP SURGICAL OCCLUDING CLIPFZP1980-01-28
1522691294333065K790413HEIFETZ ANEURYSM CLIP, LMM BLADEHCH1979-03-16
1522691395466553K781978PUNCTURE KIT, DISPOSALBE VEINFMF1978-12-12
1522691626001520K780532PERCUTANEOUS SHEATH INTRODUCER KITDYB1978-04-21
1522691169892708K772217TEMPERATURE MONITORFLL1977-12-13
1522691503768367K771752FINGER TIP CONTROL PENCILGEI1977-09-28
1522691937259874K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
1522691440954944K770356ANESTHESIA KIT, EPIDURAL, SINGLE SHOTCAZ1977-03-01
1522691479240850K770085ROBBETT MICROSURGICAL LARYNGOSCOPEEQN1977-01-21
1522691289520997K761169GRANT MODIF OF DEBAKEY ABDOM AORTA CLMPDXC1976-12-09
1522691970238243K760652JESBERG ESOPHAGOSCOPES W/AUSTINETIC S SEOX1976-12-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FZP232025-07-03
LJS152016-12-22
GAT142020-03-30
GCJ112020-04-09
DYB112013-01-04
CAZ102023-02-13
CAC102014-10-23
MSD102014-07-07
DQY92017-06-23
GEI72018-10-12
DQX72004-03-01
FOZ62007-08-30
GAM62006-05-17
KDQ51996-08-28
PEW42023-09-22
GAP42016-11-23
OBJ42013-09-26
DXC42009-10-26
EOQ41995-03-31
GCX41993-07-28
JOL41989-01-19
KNT32022-10-31
GAW32020-03-19
OCW32013-10-08
MPB32000-09-14
FMF32000-08-29
LDF31996-10-17
KCT22020-04-14
KNW22014-12-17
HCZ22009-12-03
KKX22007-10-10
FMI22007-09-26
MAI22004-11-19
GBW21999-10-05
HGI21995-03-21
BSP21993-09-22
OXC12023-10-06
GDW12021-04-28
BSO12017-03-17
FAT12014-06-16