Teleflex Medical Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Teleflex Medical Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8040412
FEI Number3009271244
NameTeleflex Medical Sdn. Bhd.
Owner & OperatorTeleflex
Contact Address3015 Carrington Mill Blvd.
Morrisville NC 27560 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLot PT 2577, Jalan Perusahaan 4
KAMUNTING Perak, 34600 MY
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter2019-12-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter2019-12-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Catheter, Retention Type, Balloon2017-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Simplastic Foley Catheters2017-02-27
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Endobronchial Tubes2015-04-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Super Safety Silk Tracheal Tube2014-06-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Nasal Safety Silk Tracheal Tube2014-06-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Humid Vent HEPA2012-12-17
Teleflex Medical Sdn. Bhd. [Teleflex]
Iso-Gard Filter Angled/Iso-Gard Filter Straight2012-06-24
Teleflex Medical Sdn. Bhd. [Teleflex]
Humid-Vent Filter2012-06-24
Teleflex Medical Sdn. Bhd. [Teleflex]
AQUA+FH/FHY2012-04-17
Teleflex Medical Sdn. Bhd. [Teleflex]
AQUA+FH/FHY2012-04-17
Teleflex Medical Sdn. Bhd. [Teleflex]
ISO-GARD HEPA FILTER-HME2012-02-10
Teleflex Medical Sdn. Bhd. [Teleflex]
ISO-ARD HEPA FILTER-HME W/PORT2012-02-10
Teleflex Medical Sdn. Bhd. [Teleflex]
HUMID-VENT FILTER COMPACT STRAIGHT2012-02-01
Teleflex Medical Sdn. Bhd. [Teleflex]
HUMID-VENT FILTER COMPACT ANGLED2012-02-01
Teleflex Medical Sdn. Bhd. [Teleflex]
Slick Set2011-10-31
Teleflex Medical Sdn. Bhd. [Teleflex]
FILTER, BACTERIAL, BREATHING-CIRCUIT2011-05-20
Teleflex Medical Sdn. Bhd. [Teleflex]
Oral/Nasal Safety Clear Trache tube cuffed, magill/murphy2011-04-04
Teleflex Medical Sdn. Bhd. [Teleflex]
AGT PVC Preform Nasal trachea tube uncuff w/ mur eye2011-04-04
Teleflex Medical Sdn. Bhd. [Teleflex]
AGT PVC Preform Oral trachea tube cuffed w/mur eye2011-04-04
Teleflex Medical Sdn. Bhd. [Teleflex]
Malecot and Pezzar Catheter2009-03-24
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch all purpose red rubber2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch all purpose Robinson / Nelation2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Silicone Coated Foley, and pediatric2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
Nelaton-Robinson catheter, cylindrical2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
Nelaton-Robinson catheter, Tiemann pattern2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
Nelaton catheter rubber, cylindrical / Robinson pattern / whistle tip / coaxial / Tiemann pattern2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
Female catheter2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
ERU Catheter PVC Tiemann Pattern2008-09-09
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Silicone Tiemann Foley2008-03-05
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Silicone Foley2008-03-05
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Pediatric Silicone Foley2008-03-05
Teleflex Medical Sdn. Bhd. [Teleflex]
RUSCH Brillant Silicone Foley catheter, 100ml2008-03-05
Teleflex Medical Sdn. Bhd. [Teleflex]
Standard Connector2008-03-05
Teleflex Medical Sdn. Bhd. [Teleflex]
Venti-Comp2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Smooth Flo Corr A Tube II2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Corrugated Tubing2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Multiple Ventilator T2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson Sampling Lines and Filters2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI SOFTFLEX2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson Anesthesia Circuit Assessories2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Gas Sampling Lines2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Corr A Tube2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Corr A Flex2006-07-11
Teleflex Medical Sdn. Bhd. [Teleflex]
Tracheal Tube2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
MULTIPLE BREATHING CIR2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Main Line Filter Kit2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Bacterial/Viral Filter2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Multiple Tracheal Tubes W/O Connect2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Teleflex2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Teleflex2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Y Connector Elbow Connector M Connector Connector2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Sher-I-Swiv Double Swivel Connector2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Connector with Barbed Elbow2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Connector Trach Tee Fitting2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Connector Oxygenator2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Tubing2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Sensor Tee2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Adaptors and Connectors2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
CPRAM Respiratory Assist Device2006-05-16
Teleflex Medical Sdn. Bhd. [Teleflex]
MULTIPLE CYSTOMETRIC GAS (CARB2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch MMG H2O2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
MULTIPLE URETHRAL CATHETERS2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Pocket Pac2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch MMG Closed System Intermittent Catheter2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Intermittent Insertion Kit2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
MULTIPLE STERILE URETHRAL CATHET2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Convatec GentleCath2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Pocket Pac2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch MMG Closed System Intermittent Catheter2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Intermittent Insertion Kit2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
MULTIPLE STERILE URETHRAL CATHET2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Convatec GentleCath2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
MULTIPLE BALLOON TYPE CATHETERS2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
BALLOON TYPE2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Trach collar2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Soft Foam Mouth Cushions2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson Endotracheal Tube Holder2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Victormedical Dual Lumen Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Oxygen Therapy Start-Up Kit2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Oxygen Nasal Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Novaplus Nasal Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Nasal Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Nasal Cannula STAR LUMEN Tubing2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Dual Lumen Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Devilbiss Nasal Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Comfort Flo Plus Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Comfort Flo Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Caire Dual Lumen Cannula2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
OSMO2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Novaplus Aerosol Drainage System2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
ISO-GARD Drain2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Water Trap2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
Hudson RCI Oxygen Tubing Water Trap2006-05-15
Teleflex Medical Sdn. Bhd. [Teleflex]
URODYNAMIC SET2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
RECTAL BALLOON CATHETER2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
BLADDER PRESSURE CATHETER2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
AbViser2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
VARIOUS TYPES OF HEAT AND MOISTURE EXCHANGERS2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
MULTIPLE HEAT2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
MOISTURE ARTIFICIAL NOSE CONDENSER2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
HUMID-VENT HEAT AND MO2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
HUMID-FLO2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
HEAT AND MOISTURE2005-07-12
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Standard FloCath2001-06-18
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch FloCath Quick2001-06-18
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch FloCath Quick kit, Female2001-06-18
Teleflex Medical Sdn. Bhd. [Teleflex]
Flocath and Easycath Intermittent Catheter2001-06-18
Teleflex Medical Sdn. Bhd. [Teleflex]
Nasopharyngeal tube rubber, Wendl pattern2001-06-18
Teleflex Medical Sdn. Bhd. [Teleflex]
Sheridan Soft-Tip Intubating Stylet2001-05-19
Teleflex Medical Sdn. Bhd. [Teleflex]
Sheridan Sher-I-Slip Intubating Stylet2001-05-19
Teleflex Medical Sdn. Bhd. [Teleflex]
Sher-I-Swiv/FO Double Swivel Connector2001-05-19
Teleflex Medical Sdn. Bhd. [Teleflex]
Rusch Endotracheal Tube Stylet2001-05-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092436496Shanghai ,China (Mainland) -> Seattle, WashingtonENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020092436496Shanghai ,China (Mainland) -> Seattle, WashingtonENDOTRACHEAL TUBE6035 CTN
2020092436496Shanghai ,China (Mainland) -> Seattle, WashingtonCONDENSER HUMIDIFIRE6035 CTN
2020092436496Shanghai ,China (Mainland) -> Seattle, WashingtonENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020092436496Shanghai ,China (Mainland) -> Seattle, WashingtonCONDENSER HUMIDIFIRE;ENDOTRACHEAL TUBE6035 CTN
2020092436496Shanghai ,China (Mainland) -> Seattle, WashingtonLATEX CATHETER;ENDOTRACHEAL TUBE6035 CTN
2020092436496Shanghai ,China (Mainland) -> Seattle, WashingtonCONDENSER HUMIDIFIRE;SILICONE CATHETER6035 CTN
2020091612113Singapore,Singapore -> Los Angeles, CaliforniaCONDENSER HUMIDIFIER469 CTN
2020091255754Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020091255754Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE6035 CTN
2020091255754Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE6035 CTN
2020091255754Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020091255754Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;ENDOTRACHEAL TUBE6035 CTN
2020091255754Shanghai ,China (Mainland) -> Long Beach, CaliforniaLATEX CATHETER;ENDOTRACHEAL TUBE6035 CTN
2020091255754Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;SILICONE CATHETER6035 CTN
2020091123541Singapore,Singapore -> Los Angeles, CaliforniaCONDENSER HUMIDIFIER469 CTN
20200909125990Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
20200909125990Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE6035 CTN
20200909125990Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE6035 CTN
20200909125990Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
20200909125990Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;ENDOTRACHEAL TUBE6035 CTN
20200909125990Shanghai ,China (Mainland) -> Long Beach, CaliforniaLATEX CATHETER;ENDOTRACHEAL TUBE6035 CTN
20200909125990Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;SILICONE CATHETER6035 CTN
20200907890Shanghai ,China (Mainland) -> Houston, TexasCONDENSER HUMIDIFIER452 CTN
2020090386450Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020090386450Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE6035 CTN
2020090386450Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE6035 CTN
2020090386450Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020090386450Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;ENDOTRACHEAL TUBE6035 CTN
2020090386450Shanghai ,China (Mainland) -> Long Beach, CaliforniaLATEX CATHETER;ENDOTRACHEAL TUBE6035 CTN
2020090386450Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;SILICONE CATHETER6035 CTN
2020090294562Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020090294562Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE6035 CTN
2020090294562Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE6035 CTN
2020090294562Shanghai ,China (Mainland) -> Long Beach, CaliforniaENDOTRACHEAL TUBE;LATEX CATHETER6035 CTN
2020090294562Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;ENDOTRACHEAL TUBE6035 CTN
2020090294562Shanghai ,China (Mainland) -> Long Beach, CaliforniaLATEX CATHETER;ENDOTRACHEAL TUBE6035 CTN
2020090294562Shanghai ,China (Mainland) -> Long Beach, CaliforniaCONDENSER HUMIDIFIRE;SILICONE CATHETER6035 CTN
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