Data / Medical devices / Malaysia / Transmedic Healthcare Sdn Bhd

Transmedic Healthcare Sdn Bhd: FDA-registered device maker in Kuala Lumpur, Malaysia, 16 510(k) clearances

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

Transmedic Healthcare Sdn Bhd is registered with the FDA (registration 3013767421) in Kuala Lumpur, Malaysia. It lists 13 device types. The FDA files 16 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013767421
Address: B4-1-1, Solaris Dutamas, No 1, Jalan Dutamas 1, Kuala Lumpur, Malaysia, 50480
Owner or operator: TRANSMEDIC HEALTHCARE SDN BHD (10091473)
Roles: Exporter to the US
First device listed: October 7, 2024
Registered through: 2026
Brand names listed: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE, INSTRUMENT, MANUAL, SURGICAL, GENERAL USE, INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT, Table and attachments, operating-room, balance, analytical

Devices it lists

Device	Product code	Class	Role	Source
Balance, Analytical	JQO	1	Exporter to the US	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Exporter to the US	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Exporter to the US	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Exporter to the US	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Exporter to the US	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Exporter to the US	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
July 25, 2024	K241361	Arthrex Synergy Vision Endoscopic Imaging System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 29, 2024	K241235	Arthrex TightRope II	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 15, 2023	K232973	Arthrex Knee FiberTak® Button Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 10, 2023	K230433	Arthrex Knotless FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 22, 2022	K221396	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 11, 2022	K222161	Arthrex Knotless FiberTak Biceps Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 6, 2022	K220947	Arthrex Knotless AC Repair Devices	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 27, 2020	K203268	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 27, 2020	K201132	Arthrex Compression Screws	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 12, 2020	K200341	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 21, 2018	K181769	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 28, 2017	K172612	FiberTak DX	MBI	Substantially Equivalent	Arthex, Inc.	accessdata.fda.gov
May 26, 2017	K171296	SutureTape	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 19, 2015	K151230	Arthrex FiberTak Anchors	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 3, 2013	K130458	KNOTLESS FIBERTAK SUTURE ANCHOR	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 7, 2001	K002469	IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)	EBW	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov

Compare with other makers

Updated July 25, 2024. 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.