Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004365956

FEI Number

3004365956

Entity Name

Teleflex Medical de Mexico, S. de R.L. de C.V.

City/State/Country

NUEVO LAREDO Tamaulipas, MX

Establishment Address

Ave. Industrias No 5954, Parque Industrial Finsa,, NUEVO LAREDO Tamaulipas 88275, MX

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Teleflex (Owner Number: 9062981)

Owner / Operator Contact Address

3015 Carrington Mill Blvd., Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K010420

PMA Number

N/A

All Registered Proprietary Names

POLYSORB SYNTHETIC ABSORBABLE SUTUR DEKNATEL Polydek Deklene Tevdek Deklene Maxx Cottony RUSCH AGT PVC PREFORM NASAL PLEUR-EVAC PLEUR EVAC CHEST DRAINAGE SYSTEM PLUER-EVAC MULTIPLE VACUUM COLLECTION BOTTLES Force Fiber Esophageal Stethoscope Autofuser NEXTSTITCH POLYETHYLENE SYNTHETIC NONABSORBABL Cottony II, Silky II Polydek Tevdek II Sprotte Needle Rusch FloCath Quick kit, Female Rusch FloCath Quick Rusch Standard FloCath Flocath and Easycath Intermittent Catheter CARRIER LAHEY PILLING MULTIPLE LIGATURE COLD WATER BOTTLES PILLING HOT WATER BOTTLE RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS POLYPROPYLENE SYNTHETIC NONABSORBAB Force Fiber Arrow-Clarke Pleura-Seal Thoracentesis Kit Pilling Mouth Gag Oberto Mouth prop PILLING STAINLESS STEEL SUTURE NEEDLES PILLING PLEUR-EVAC CHEST DRAINAGE SYSTEM Force Fiber Bondek Monodek PILLING MULTIPLE GASTRO-UROLOGY TOURNIQUETS Gibeck RCI Softech Bi-Flo Cannula Hudson RCI Softech Bi-Flo Cannula MULTIPLE SUCTION CATHETERS AND TIPS Deknatel Thoracic Spirometer Therapeutic (Incentive) Tracheal Tube QUAPAK Aquapak ConchaTherm LHF DEKNATEL Cottony Force Fiber BONDEK MULTIPLE BREATHING CIR Hudson Anesthesia Circuit Assessories RUSCH Double lumen Bronchial tube, White RUSCH Double lumen Bronchial tube, Carlens Arrow PLEUR-EVAC (K792088) AORTIC OCCLUDER MULTIPLE UMBILICAL LMA ProSeal LMA Fastrach (SU) LMA Unique (Silicone Cuff) LMA Supreme LMA Flexible (SU) Oropharyngeal Guedel Tube Black LMA Cuff-Deflator LMA Unique (Silicone Cuff) Cuff Pilot LMA ProSeal Introducer LMA Unique Evo Cuff Pilot LMA Protector Cuff Pilot LMA Fastrach LMA Flexible LMA ProSeal Cuff Deflator LMA Protector LMA Unique Evo LMA Classic Excel LMA Unique LMA Gastro Cuff Pilot LMA Unique PreCurved LMA Classic LMA Flexible PreCurved LMA Unique PreCurved Cuff Pilot LMA NovaPlus LMA Supreme Plus Pack LMA Flexible PreCurved Cuff Pilot MADgic Airway LMA Fastrach Stabiliser Rod LMA Unique (S) Cuff Pilot LMA Flexible (S) LMA Unique (S) LMA Flexible (S) Cuff Pilot Cath-Guide Guedel Airway Airway Lifesaver Kit Ovassapian Airway Dual Channel Airway Nasopharyngeal tube rubber, Wendl pattern Abdominal Paracentesis Kit Nonabsorb Polypropylene Synthetic Suture OPCAB IRRIGATION SYSTEM OPCAB 3 IN 1 CLEARSITE CUNNINGHAM PENILE CLAMP PILLING EVACUPAK MULTIPLE NONINVASIVE TUBINGS PLEUR-EVAC RUBBER LATEX AND PVC TUBING Imager II MULTIPLE COLLECTIONS SYSTEMS PLEUR-EVAC Rusch PEEP Valve SnapLock Clamp Fastener Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter Arrow® SnapLock Catheter/Syringe Adapter Sprotte Needle Polyglycolytic Acid Absorbable Sutr Bondek Bondek Plus Deknatel ORTHODEK various clip appliers MULTIPLE FIBEROPTIC RETRACTOR RETRACTOR FIBEROPTIC PILLING SAPH LIFE Deknatel®, Deklene®, Deklene® Maxx, Capio Force Fiber DEKNATEL POLYPROP, POLYETHYLE NYLON AND SILK Hudson RCI Aerosol Connector Novaplus Oxygen Supply Tubing Hudson RCI Pressure Lines Rusch Pecan Breathing Bag Hudson RCI STAR LUMEN Tubing Novaplus Oxygen Supply Tubing Connector Rusch Anesthesia Circuit Tubing Hudson RCI Oxygen Supply Tubing Connector Rusch Connector End Cap Female Rusch Connector Logan Bow Gas Sampling Lines Hudson RCI Pressure Monitoring Lines Hudson Pressure Tubing Hudson RCI Aerosol T-Connector CORR-A-TUBE Hudsonas sampling lines and filters Oxygen Supply Tubing Hudson RCI Connector Devilbiss Oxygen Supply Tubing Connector Hudson Anesthesia Circuit Assessories Rusch Pressure Tubing Novaplus Addipak Unit Dose Vial Devilbiss STAR LUMEN Tubing Hudson RCI Flow Meter Adaptor Rush Pressure Tubing Mindray Adaptor Patient Airway Hudson RCI Oxygen Supply Tubing Rusch Xmas Tree Adaptor Hudson RCI Adaptors and Connectors MULTIPLE METAL URETERAL PORGES DORMIA Triflo MULTIPLE FILIFORM AN Rusch Follower-Bougie Rusch Filiform-Straight Tip Rusch Follower-Catheter Rusch Filiform-Spiral Tip Bite Gard Hudson Bite-Guard Bite-Gard Oral Bite Block Rusch Ureteral Catheter-Whistle Tip Rusch Ureteral Catheter-Cone Tip Rusch Ureteral Catheter-Round Tip Rusch Ureteral Catheter-Olive Tip Rusch Ureteral Catheter-Braasch Bulb Rusch Ureteral Catheter-Blassucci Spiral Infant Feeding Tube Enfuse, Entube, various CATHETER SPIGOTS PILLING MULTIPLE CATHETER ACCESSORIES SUPERGLIDE DD STENT BALLOON TYPE MULTIPLE BALLOON TYPE CATHETERS DEKNATEL MYOWIRE-ATEMPORARY CARDIAC PACING W PILLING Rusch Endotracheal Tube Holder Soft Foam Mouth Cushions Trach collar Facemask Silicone Anesthesia Face mask with / without hook ring, black Anesthesia Face mask, pediatric Rusch Clear Comfort Rusch Sure Seal Imager II Urology Torque Catheters MULTIPLE URETERAL CATHETERS CONNECTOR URETERAL CATHETER EPIDURAL TUOHY Needle, Conduction, ,Anesthetic BALLPEN SPINAL NEEDLE W/WO INTRODUC MULTIPLE SUPRAPUBIC CA HUDSON RCI LIFESAVER DISPOSABLE MANUAL RESUSCITATOR Hudson RCI Disposable PEEP Valve Gibeck RCI Disposable PEEP Valve RUSCH MANUAL RESUSCITATOR TracheoFix-Set PILLING Rusch Lite Laryngoscope Kit MULTIPLE FIBEROPTIC Y Connector Elbow Connector M Connector Connector Sher-I-Swiv Double Swivel Connector CPRAM Respiratory Assist Device Hudson RCI Adaptors and Connectors Rusch Connector Oxygenator Rusch Connector Trach Tee Fitting Hudson RCI Tubing Hudson RCI Sensor Tee Rusch Connector with Barbed Elbow Safety Trocar Cannula MULTIPLE CLINICAL PILLING Force Fiber S-FIBRE BightForceTM ULTRABRAID Aquatherm Rusch Breathing Bag Hudson Neoprene Pecan Breathing Bag Rusch Pecan Breathing Bag Hudson Anesthesia Circuit Hudson RCI Test Lung Hudson Anesthesia Breathing Bags Hudson Anesthesia Circuit Assessories Rusch Anesthesia Breathing Bags Pleur-evac FILIFORMS FOLLOWERS BOUGIE PILLING MULTIPLE UROLOGICAL BOUGIES Teleflex Rusch Head Harness Hudson Mask Harness Hudson Head Harness MULTIPLE PUNCHES PILLING KMEDIC GENERAL AND PLASTIC SURGERY MULTIPLE SURGICAL PUNCHES MULTIPLE NEPHROSTOMY CATHETER GENERAL AND PLASTIC SURGERY INTRODUCTION DRAINAGE CATHETER INTRODUCERS PLEUR-EVAC MULTIPLE CATHETER CONNECTORS INTRODUCER Humidifier Filter, various PILLING PILLING DEKNATEL MULTIPLE BITE BLOCKS Hudson RCI Variable concentration Large Volume Nebulizer (1770). Model Numbers: HUD1770 & 1770 Pilling MULTIPLE CUSHION FLOATIONS INFLATION CUSHION Pleur-evac Suction catheter with saline Deknatel Multiple Tracheal Tubes W/O Connect PILLING EWALD STOMACH SYSTEM SIMS Anesthesia Breathing Circuit Hudson Sampling lines and Filters Rusch Anesthesia Circuit Accessories Rusch Pediatric Rebreathing Circle Systems ISO-GARD Drain Circuit Technology Hudson RCI Conventional Breathing Circuits Rusch Face Mask Plug Rusch CPRAM Anesthesia Circuits Hudson CPRAM Anesthesia Circuits Rusch sampling lines and filters Anesthesia Circuit Sheridan Flex-C-Pap Rusch Adult Anesthesia circuit Rusch Disposable Adult Rebreathing Circle Systems Rusch RCI Conventional Breathing Circuits Hudson Anesthesia Circuit Accessories Rusch EPDM FLEX CONNECTOR Rusch Anesthesia Circuit Rusch Adult Rebreathing Circle Systems Hudson Disposable Adult Rebreathing Circle Systems Hudson Pediatric Rebreathing Circle Systems Hudson RCI Rusch RCI Hudson Non-Rebreathing Single Limb Systems Hudson Adult Rebreathing Circle Systems Hudson Anesthesia Circuit Rusch Non-Rebreathing Single Limb Systems Hudson RCI Mouthpiece MONODEK MULTIPLE INTERMITANT MANDATORY Hudson RCI IMV System PILLING Hudson RCI Temperature Indicator MULTIPLE SURGICAL INSTRUMENT GUIDES MULTIPLE POSITIVE END EXPIRATOR 6.5mm Biozip Hss 5mm Biozip Hss Hudson Sampling Lines and Filters Gas Sampling Lines Multiple Ventilator T Corr A Tube Smooth Flo Corr A Tube II Corr A Flex Rusch Sampling Lines, Rusch Anesthesia Circuit Accessories Catheter Mount Rusch Corrugated Tubing Venti-Comp Gibeck RCI SOFTFLEX Hudson Anesthesia Circuit Assessories CLEANING TRACHEAL TUBE Cleaning Brush KMEDIC PILLING MULTIPLE TRACHEAL T MULTIPLE TRACHEOSTOMY TUBES W Tracheostomy Tube Pleur-evac INTRODUCER NEEDLE Disposable Aortic Punch ConchaSmart Column Hudson RCI Neptune Heated Humidifier Comfort Flo Humidification System MULTIPLE, AUTOTRANSFUSION BAG PLEUR-EVAC Low Compliance Concha Column Comfort Flo Humidification System Pilling Esophageal Bougies PILLING Endotest Cuff Pressure Gauge Endotest Replacement Tube MULTIPLE GEN. PURPOSE LAB EQ Pilling Lifesaver Isolation Kits Hudson Isolation Valve GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG PLEUR-EVAC PNEUMONECTOMY MINI-SAHARA MULTIPLE INTRAVASCULAR CA EZ-Stabilizer INTRAVASCULAR CATHETER SECUREMENT HUMID-VENT HEAT AND MO MULTIPLE HEAT HUMID-FLO MOISTURE ARTIFICIAL NOSE CONDENSER HEAT AND MOISTURE VARIOUS TYPES OF HEAT AND MOISTURE EXCHANGERS FlexTip Plus Epidural Catheter EquipLite Standard Laryngoscope Blades and Handles Rusch GreenLite Shucman 2 DispoLED DispoGrip GreenSpec EquipLED TruLED TruLite Secure GreenLED Fiber Optic Laryngoscope Blades and Handles Dolphin SnapLight Rusch Polaris MULTIPLE STAINLESS STEE and Monofiliment Sutures Stainless Steel, Multifiloment, SAPH IOOP APH IOOP NEXTSTITCH POLYETHYLENE SYNTHETIC NONABSORBABL DEKNATEL SAPHLOOP PILLING Canyons Wound Irrigation System MULTIPLE IRRIGATING IRRIGATING Rusch Greenspec Laryngoscope Handle PILLING MULTIPLE TEMPORARY WECK PILLING Tracheoflex set short with / without Cuff and Phonation Tracheoflex set short with / without Cuff Pleur-evac BED PAN RUBBER ROUND MULTIPLE BED PANS RS MULTIPLE ATOMIZER AND TIP ENT NON-VENTILATORY NEBULIZER MAD Nasal Mist MAD Nasal VaxINator Mucosal Atomization Device (MAD) NON=VENTILATORY MEDICINAL NEBULIZE AVA NEB NEBULIZER TIP ENT MULTIPLE ATOMIZERS ATOMIZER PLEUR-EVAC(R) A-8020--INFANT CHEST BOUGIE MULTIPLE ENT ESOPHAGEAL BOUGIES Pilling MALONEY AND HURST ESOPHAGEAL MALONEY AND HURST BOUGIE MULTIPLE BREATHING CIR Bacterial/Viral Filter Hudson RCI Main Line Filter Kit ISO-Gard Mask Teleflex Teleflex URODYNAMIC MEASUREMENT SYSTEM DUET SUTURE ANCHOR DUET W/HI-FI IMPACT W/HI-FI LMA Fastrach ETT Rush Tuohy Needle PLEUR-EVAC CHEST DRAINAGE SYSTEM ULTRABRAID MULTIPLE SUPRAPUBIC CA 3mm Xcel 6.5mm Biozip 5mm Biozip Force Fiber OrthoTape PLEUR-EVAC CHEST DRAINAGE SYSTEM MULTIPLE OCCLUSIVE WO Rusch Asherman Chest Seal Convatec GentleCath MULTIPLE STERILE URETHRAL CATHET Rusch Intermittent Insertion Kit Rusch MMG Closed System Intermittent Catheter Rusch Pocket Pac

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2009-10-09
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2016-05-23
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2016-05-23
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-11-03
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-11-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-11-03
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-11-03
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-11-03
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2006-05-16
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2010-11-03
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2006-05-16
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-03-11
BZW	Stethoscope, Esophageal	Anesthesiology	Class 1	868.1910	2001-06-18
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2015-09-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2005-12-20
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2013-09-18
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2001-06-18
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	1995-09-29
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2001-05-15
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2006-05-16
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2005-09-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2011-06-15
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2014-06-11
LRL	Cushion, Hemorrhoid	Unknown	Class U	N/A	2011-05-27
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1995-10-02
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1992-08-03
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2010-11-03
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2019-01-28
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2019-01-28
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-01-28
EYR	Tourniquet, Gastro-Urology	General, Plastic Surgery	Class 1	878.5900	2001-05-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2006-05-15
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1995-10-02
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2023-07-11
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2006-05-16
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2006-05-16
GAO	Suture, Nonabsorbable	General, Plastic Surgery	Class 2	878.4495	2016-11-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-11-03
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-11-03
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-11-03
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2016-11-03
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-11-03
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2016-11-03
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-11-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-03-11
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2005-12-20
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2005-07-12
BTS	Tube, Bronchial (W/Wo Connector)	Anesthesiology	Class 2	868.5720	2007-05-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-06-21
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2009-08-20
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	1997-07-01
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2001-06-18
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2001-06-18
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-06-11
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2005-12-20
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2006-11-24
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2006-05-15
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2006-11-24
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-09-10
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2005-09-13
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2014-01-03
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2016-03-14
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2017-05-18
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-03-11
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2009-10-09
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2011-08-31
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2006-05-15
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2020-04-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-03-11
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	1992-08-03
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	1992-08-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	1992-08-03
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	1992-08-03
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2006-05-16
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2006-05-15
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2011-11-22
FBW	Filiform And Filiform Follower	Gastroenterology, Urology	Class 1	876.5520	2006-05-15
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2011-08-24
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2011-02-25
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2011-03-03
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1997-07-01
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-18
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2006-05-15
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2009-08-28
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2006-05-15
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2006-07-11
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-04-12
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2001-05-16
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	1985-04-29
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2005-07-12
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2006-05-16
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2006-05-16
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2006-05-15
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2006-05-16
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2021-05-05
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2006-05-15
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-03-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-03-11
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2006-05-15
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2005-07-12
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2015-01-15
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2006-05-15
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2006-05-16
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2001-06-18
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-05-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-03-20
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2006-05-15
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2006-05-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2011-03-11
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2011-03-03
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2006-05-15
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-11-23
JXL	Block, Bite	Neurology	Class 2	882.5070	2006-05-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-08-16
LZB	Finger Cot	General Hospital	Class 1	880.6250	2011-05-27
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2001-06-18
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1995-10-05
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2011-10-25
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2006-05-16
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2005-03-21
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2005-07-12
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2006-08-30
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2005-09-13
CBO	Attachment, Intermittent Mandatory Ventilation (Imv)	Anesthesiology	Class 2	868.5955	2006-05-15
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2006-04-19
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-09-05
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2006-05-15
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-03-20
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2006-07-11
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2006-05-16
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2006-05-16
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2013-03-07
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1995-10-02
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2014-03-18
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2010-11-05
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2012-06-14
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2009-10-09
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2011-02-25
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	2014-06-25
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2001-06-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2006-05-15
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2006-05-15
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2006-05-15
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2011-03-03
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2001-05-19
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-05-15
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2005-07-12
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-02-08
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2017-02-08
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2005-03-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-01-13
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	1992-08-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2002-12-13
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2001-06-18
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2006-05-15
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2006-05-16
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2006-05-16
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2015-01-15
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2016-12-06
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-12-06
FOB	Bedpan	General Hospital	Class 1	880.6730	2001-05-15
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2006-05-15
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2006-11-24
KCD	Bougie, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2006-05-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2006-05-16
CBN	Apparatus, Gas-Scavenging	Anesthesiology	Class 2	868.5430	2015-04-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2006-05-16
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2006-05-16
FAP	Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Gastroenterology, Urology	Class 2	876.1620	2005-03-21
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-01-23
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-23
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-05-20
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2010-05-21
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2010-11-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-12-06
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2006-05-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-20
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-04-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2010-11-03
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-03-20
MGP	Dressing, Wound And Burn, Occlusive	Unknown	Class U	N/A	2006-05-15
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2006-05-15
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2006-05-15

Official Correspondent

Divya Raman

US Agent Details

Divya Raman Business: Teleflex, Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

Teleflex

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013515223	T.K. India Pvt. Ltd.	Chandigarh, IN
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
3007134520	TELEFLEX MEDICAL	ATHLONE Westmeath, IE
8040412	Teleflex Medical Sdn. Bhd.	KAMUNTING Perak, MY
3005232773	Teleflex Medical OEM LLC	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Similar Registrations

Registration Number	Establishment Name	Location
2210968	ETHICON, INC.	Somerville, NJ, US
3014279513	MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI	Cankaya Ankara, TR
1221601	Teleflex Medical LLC	MANSFIELD, MA, US
3011689956	DYLAN LUCAS INTERNATIONAL INC	Vaughan Ontario, CA
3018052045	AKSHAR GAMMA STERILES LLP	THANE Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004365956. Last updated year: 2026. Please use registration number 3004365956 when referencing this establishment in official correspondence.