FDA.reportPublic FDA data

Teleflex Medical LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12210191221019Teleflex Medical LLC1N2026-01-0150 PLANTATION DRIVE Jaffrey NH US 03452
12216011221601Teleflex Medical LLC1N2026-01-01375 FORBES BLVD. MANSFIELD MA US 02048
30111373723005747797Teleflex Medical LLC1Y2026-01-013015 Carrington Mill Blvd Morrisville NC US 27560

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1754631093467088P990037VASCULAR SOLUTIONS DUETT SEALING DEVICEMGB2000-06-22
1754631440833666P180025MANTA Vascular Closure DeviceMGB2019-02-01
1754632060436755P100014SOLESTA INJECTABLE GELLNM2011-05-27
1754631565065159P000029DEFLUX INJECTABLE GELLNM2001-09-24
1754631815064191N18286GELFOAMLMF1983-07-08
1754631285294749K994352SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896CAF2000-03-22
1754631815496054K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
1754631080050838K993786RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHYBTR2000-02-02
1754631825344893K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
1754631162764027K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43BTT2000-05-24
1754631622323101K993157HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240FZP1999-12-17
1754631890295485K992904MINI-PORTGBW1999-10-05
1754631082195805K992664TFX MEDICAL STYLET CATHETERDRB2000-04-13
1754631800988254K992174PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMPDXC2000-03-23
228301714885411K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-09-03
1754631714885411K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-09-03
1754631029403629K991580ILM ENDOTRACHEAL TUBEBTR2000-02-04
1754631188029990K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
228301058369042K991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-06-22
1754631058369042K991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-06-22
1754631839921168K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65MCW1999-05-04
1754631883395763K990619RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILEBTR1999-08-03
1754631681808333K990561OPTICAL FORCEPSJEK1999-05-14
1754631433096457K990556ESOPHAGEAL INTUBATION DETECTORBTR1999-03-26
1754631775694339K983010SELF CATH SET/SAFETY CATHFCM1999-02-12
1754631373752975K982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250CAC1998-12-18
1754631141821611K982408AEROTEE, MODEL # 1001CAF1998-09-14
1754631802383666K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPSFZP1998-08-10
1754631324269584K982128SHIKANI-FRENCH SPEAKING VALVEJOH1998-10-23
1754631106664981K9814150-20 CM H20 PEEP VALVEBYE1998-07-14
228301182344798K981322CUTALON NYLON POLYAMIDE SURGICAL SUTUREGAR1998-07-07
1754631182344798K981322CUTALON NYLON POLYAMIDE SURGICAL SUTUREGAR1998-07-07
1754632049876565K974793ELMED ESU 120 M/M DIGITALGEI1998-03-19
1754632070639444K974419RUSCH SIMPLASTIC COUNCILL TIP CATHETEREZL1998-01-27
1754631175312418K972423RUSCH TRACHEOFIX-SETJOH1998-02-13
1754631590040410K972184RUSCH BRILLANT SILICONE FOLEY CATHETEREZL1998-01-08
1754631171224525K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
1754631917104539K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETDYB1998-02-13
1754631855666872K970021RUSCH SUPRAPUBIC TRAYKOB1997-02-07
1754631913361049K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)CAH1997-12-02
1754631233256124K964719HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATORBTM1997-02-21
1754631214697065K964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)CAH1997-04-15
1754631132793575K964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGCAC1996-12-31
1754631580360599K964056RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILEJOH1997-10-10
1754631848590568K963993RUSCH SIMPLASTIC FOLEY CATHETERIZATION SETFCM1996-12-17
1754631555305704K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMCAC1997-04-22
1754631978717364K963779RUSCH ENTERAL FEEDING TUBEFPD1997-05-23
1754631259168468K963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)CAC1996-11-08
1754631256891744K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRKDQ1996-08-28
1754631192437532K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
1754631064657218K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERFAP1996-08-27
1754631101279516K961977KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBECBI1996-07-31
1754631565440657K961914BACTERIA/VIRAL FILTERCAH1996-08-14
1754631343412923K961840RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHYBTR1996-06-27
1754631227178320K961837RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHYBTR1996-08-16
1754631158414009K961150DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULACCK1996-09-10
1754631103997166K960883INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8GCJ1996-03-20
1754631898856062K955495RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILEBTR1996-06-27
1754631775896385K954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORTCAH1996-05-02
1754631844318093K954585RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILEBTR1996-05-10
1754631768576597K952573RUSCH URODYNAMIC RECTAL BALLOON CATHETERFEN1995-06-15
1754631895111139K952187RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILEKOB1995-07-25
1754631367150613K952084HUMID-VENT FILTER PEDIBYD1995-06-12
1754631586435039K951091RUSCH ENDOBRONCHIAL TUBE SETSBTS1995-06-08
1754631006394467K951046RUSCH ENDOTEST CUFF PRESSURE MONITORBSK1995-04-06
1754632061591535K950965KARL STORZ STENT APPLICATOR FORCEPSEOQ1995-03-31
1754631238927846K944552PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIPFZP1994-11-07
1754631515643423K944301HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380BTM1994-12-21
1754631427393252K943719VISISTAT STAPLERGDT1994-08-24
1754631214794697K942986ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)HGI1995-03-21
1754631764630226K942757ASHERMAN CHEST BANDAGEMGP1994-08-01
1754631306263703K942628ESOPHAGEAL INTUBATION DETECTOR BULBBTR1994-08-18
1754631589976487K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
1754631968493552K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONSKNT1994-09-28
1754632006827772K93133816 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)HGI1994-02-16
1754631776720784K931166RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EYBTR1993-06-22
1754631313255887K931165RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYEBTR1993-06-22
1754631013460909K931164RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EYBTR1993-06-23
1754631396510086K931163RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYEBTR1993-06-23
1754631111791327K930741ESOPHAGEAL INTUBATION DETECTORBTR1993-08-07
228301695476545K930740SURGICAL SUTURE, NONABSORABLE STAINLESS STEELGAQ1994-07-26
1754631695476545K930740SURGICAL SUTURE, NONABSORABLE STAINLESS STEELGAQ1994-07-26
228301187210249K930739SUTURES POLYPROP., POLYETHELINE, NYLON & SILKGAP1994-07-26
1754631187210249K930739SUTURES POLYPROP., POLYETHELINE, NYLON & SILKGAP1994-07-26
228301073682262K930738SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCGAL1994-07-26
1754631073682262K930738SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCGAL1994-07-26
1754631769970394K930525MICRO MIST(TM) NEBULIZERCAF1993-09-29
1754631644996377K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
1754631222861158K925559BILIARY STONE DISLODGERLQR1992-12-17
1754631321936795K925508RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIPBTR1993-09-02
1754631885192416K925507RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIPBTR1993-09-02
1754631948172345K925506RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYEBTR1993-08-02
1754631659403283K925505RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYEBTR1993-09-02
1754631952550559K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
1754631369981882K924337PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYSGCX1993-07-28
1754631220720538K923946CONCHATHERM IV HEATED MOLECULAR HUMIDIFIERBTT1994-10-18
1754631397618232K920167NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KELHBI1992-03-23
1754631937999169K913302DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIEDGDY1992-07-23
1754631552258888K911915HEMOCLIP IIFZP1992-01-09
228302006309410K911905DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIEDGAW1991-07-02
1754632006309410K911905DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIEDGAW1991-07-02
1754631386767489K911656PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYSTCAC1991-08-13
1754631176245811K911100MEHIGAN-PILLING PHLEBETOME TMMGZ1991-06-21
1754631474123204K911099MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINEDWX1991-06-25
1754631637234313K905768PLEUR-EVAC CHEST DRAINAGE SYSTEMSKDQ1991-02-11
1754631784187419K905229LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETSFGE1991-01-18
1754631185328906K904507PILLING BRUSH VALVULOTOMEDWQ1991-03-01
228301613763593K903643DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTUREGAW1990-12-24
1754631613763593K903643DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTUREGAW1990-12-24
1754631345757207K903083NEONATAL VENTILATOR CIRCUITBZO1990-12-27
1754631790377422K902327EMBOLECTOMY CATHETERDXE1991-02-25
1754631402892626K902062PEEP VALVEBYE1990-09-04
1754631741841267K901303HORIZON SURGICAL LIGATING AND MARKING CLIPDSS1990-06-05
1754631455946856K900783MDI ADAPTORCAF1990-07-18
1754631557359422K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1990-07-24
1754631015662656K897046LASER RESISTANT TRACHEAL TUBECBI1990-03-23
1754631276926141K896697PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAIKDQ1990-02-08
1754631889994627K896136INFANT C.P.A.P. MONITORCAP1990-01-09
1754631229828239K895747VENTILARM II PORTABLE AIRWAY PRESSURE MONITORCAP1989-10-27
228301598365700K895579POLYSORB SYNTHETIC ABSORBABLE SUTUREGAN1990-07-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GAT362026-05-06
BTR302025-04-29
FZP242025-07-03
DQY192022-08-18
FMI192021-03-22
BTT182014-11-24
CAZ132016-10-04
DQX122023-05-05
GCJ122020-04-09
CAF112016-07-26
QSX102020-06-26
CAC102014-10-23
GAM102006-05-17
GEI92018-10-12
DYB92018-05-09
KNT82022-10-31
CBI72018-11-02
OCW72018-02-12
CAH72012-09-21
PEW62023-09-22
GAW62020-03-19
KOD62019-05-24
DXC62014-10-23
EZL52024-08-01
QSY52018-12-24
GAP52016-11-23
KNW52014-12-17
FOZ52007-08-30
KDQ51996-08-28
FAP51996-08-27
NEW42026-07-09
BTO42024-03-22
BSP42019-08-21
BWF42019-07-01
GEX42010-01-07
MSD42004-05-14
JOH42003-03-28
EOQ41995-03-31
GCX41993-07-28
POD32025-03-18