Data / Medical devices / Malaysia / Teleflex Medical Sdn. Bhd.

Teleflex Medical Sdn. Bhd.: FDA-registered device maker in KAMUNTING Perak, Malaysia, 29 510(k) clearances

Name: Teleflex Medical Sdn. Bhd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Teleflex Medical Sdn. Bhd. is registered with the FDA (registration 8040412) in KAMUNTING Perak, Malaysia. It lists 17 device types. The FDA files 29 510(k) clearances under its listings, the newest dated September 23, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 8040412
FEI number: 3009271244
Address: Lot PT 2577, Jalan Perusahaan 4, KAMUNTING Perak, Malaysia, 34600
Owner or operator: Teleflex (9062981)
Roles: Manufacturer, Specification developer
First device listed: May 19, 2001
Registered through: 2027
Brand names listed: AGT PVC Preform Nasal trachea tube uncuff w/ mur eye, AGT PVC Preform Oral trachea tube cuffed w/mur eye, BALLOON TYPE, Bacterial/Viral Filter, Bladder Catheter Tiemann, CPRAM Respiratory Assist Device, Catheter Mount, Convatec GentleCath and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Nasopharyngeal	BTQ	1	Manufacturer	accessdata.fda.gov
Catheter, Balloon Type	GBA	1	Manufacturer	accessdata.fda.gov
Catheter, Coude	EZC	2	Manufacturer	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Manufacturer	accessdata.fda.gov
Catheter, Straight	EZD	2	Manufacturer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Manufacturer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Manufacturer	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Manufacturer, Specification developer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Manufacturer	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Manufacturer	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Manufacturer	accessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	FCM	2	Manufacturer	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Manufacturer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 23, 2026	K261418	Liquick X-treme, Liquick X-treme Plus	EZD	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
April 29, 2025	K242495	LMA Fastrach ETT SU	BTR	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
August 1, 2024	K232469	Rüsch Latex Gold Foley Catheter	EZL	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
August 29, 2022	K222279	Rusch Intermittent Urethral Catheters	EZC	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
May 24, 2019	K181979	Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter	KOD	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
May 8, 2019	K183461	Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter	GBM	Unknown	Teleflexmedical, Inc.	accessdata.fda.gov
May 5, 2017	K161770	Rusch Silicone Foley Catheter	EZL	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
February 24, 2017	K162989	Rusch Simplastic Foley Catheters	EZL	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
April 15, 2015	K141888	RUSCH ENDOBRONCHIAL TUBES	CBI	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
September 21, 2012	K112958	HUMID-VENT HEPA	CAH	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
July 1, 2002	K020714	RUSCH FLONEIL; FLOCATH INTROGEL	GBM	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
May 9, 2001	K010420	RUSCH MMG/O'NEIL CATHETER	FCM	Substantially Equivalent	Rusch, Inc.	accessdata.fda.gov
February 18, 2000	K000070	FLOCATH	KOD	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
February 2, 2000	K993786	RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY	BTR	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
August 3, 1999	K990619	RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE	BTR	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
February 13, 1998	K972423	RUSCH TRACHEOFIX-SET	JOH	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
January 8, 1998	K972184	RUSCH BRILLANT SILICONE FOLEY CATHETER	EZL	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
December 2, 1997	K965016	ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)	CAH	Substantially Equivalent	Gibeck, Inc.	accessdata.fda.gov
April 15, 1997	K964382	HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)	CAH	Substantially Equivalent	Gibeck, Inc.	accessdata.fda.gov
August 16, 1996	K961837	RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY	BTR	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
August 14, 1996	K961914	BACTERIA/VIRAL FILTER	CAH	Substantially Equivalent	Hudson Respiratory Care, Inc.	accessdata.fda.gov
June 27, 1996	K961840	RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY	BTR	Substantially Equivalent	Rusch Intl.	accessdata.fda.gov
May 2, 1996	K954828	ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT	CAH	Substantially Equivalent	Gibeck, Inc.	accessdata.fda.gov
June 12, 1995	K952084	HUMID-VENT FILTER PEDI	BYD	Substantially Equivalent	Gibeck, Inc.	accessdata.fda.gov
June 23, 1993	K931164	RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY	BTR	Substantially Equivalent	Rusch, Inc.	accessdata.fda.gov
June 23, 1993	K931163	RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE	BTR	Substantially Equivalent	Rusch, Inc.	accessdata.fda.gov
June 22, 1993	K931166	RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY	BTR	Substantially Equivalent	Rusch, Inc.	accessdata.fda.gov
June 22, 1993	K931165	RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE	BTR	Substantially Equivalent	Rusch, Inc.	accessdata.fda.gov
June 24, 1988	K881657	HUMID-VENT FILTER	BYD	Substantially Equivalent	Gibeck Respiration	accessdata.fda.gov

Compare with other makers

Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.