Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013767421

FEI Number

3013767421

Entity Name

TRANSMEDIC HEALTHCARE SDN BHD

City/State/Country

Kuala Lumpur Kuala Lumpur, MY

Establishment Address

B4-1-1, Solaris Dutamas, No 1, Jalan Dutamas 1, Kuala Lumpur Kuala Lumpur 50480, MY

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

TRANSMEDIC HEALTHCARE SDN BHD (Owner Number: 10091473)

Owner / Operator Contact Address

B4-1-1, Solaris Dutamas, No 1, Jalan Dutamas 1, Kuala Lumpur, MY-14 50480, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K002469

PMA Number

N/A

All Registered Proprietary Names

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE balance, analytical Table and attachments, operating-room INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-01-10
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-07-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-01-10
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2025-07-25
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-07-25
JQO	Balance, Analytical	Clinical Chemistry	Class 1	862.2050	2025-07-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2024-10-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-07-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-10
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2025-01-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Rogers Business: Arthrex Inc. Email: Regulatory_Affairs@Arthrex.com Phone: (800) 9337001

Related Public Records

Same Entity

TRANSMEDIC HEALTHCARE SDN BHD

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

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3010146686	Community Blood Center dba Solvita	Kettering, OH, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3003604053	SMITH & NEPHEW INC.	ANDOVER, MA, US
3014262693	Arthrex (Shanghai) Co., Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013767421. Last updated year: 2026. Please use registration number 3013767421 when referencing this establishment in official correspondence.