Medical device makers in Malaysia: 230 FDA-registered establishments

Name: FDA-registered medical device makers in Malaysia
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

230 establishments in Malaysia are registered with the FDA to make medical devices for the US market, listing 659 device types. 104 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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MalaysiaCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Polymer Patient Examination Glove	LZA	65
Medical Glove, Specialty	LZC	53
Latex Patient Examination Glove	LYY	46
Fentanyl And Other Opioid Protection Glove	QDO	40
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	36
Surgeon'S Gloves	KGO	27
Orthopedic Manual Surgical Instrument	LXH	9
Accessory, Surgical Apparel	LYU	8
Screw, Fixation, Bone	HWC	7
Instrument, Manual, Surgical, General Use	MDM	7
Plate, Fixation, Bone	HRS	7
Bedding, Disposable, Medical	KME	7
Pin, Fixation, Smooth	HTY	6
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	6
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	6
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	6
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	6
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	6
Rod, Fixation, Intramedullary And Accessories	HSB	6
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	6
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	6
Transducer, Ultrasonic, Diagnostic	ITX	6
Retractor	GAD	6
Clamp	HXD	6
Guide, Surgical, Instrument	FZX	6
Condom	HIS	6
Catheter, Retention Type, Balloon	EZL	6
Washer, Bolt Nut	HTN	5
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	5
Bit, Drill	HTW	5
Nail, Fixation, Bone	JDS	5
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	5
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	5
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	5
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	5
Nasopharyngoscope (Flexible Or Rigid)	EOB	5
Neurological Stereotaxic Instrument	HAW	5
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	MBL	5
Bronchoscope (Flexible Or Rigid)	EOQ	5
Tourniquet, Nonpneumatic	GAX	5
Template	HWT	5
Garment, Protective, For Incontinence	EYQ	5
Toothbrush, Manual	EFW	5
Tray, Surgical, Instrument	FSM	5
Handle, Scalpel	GDZ	5
Impactor	HWA	5
Countersink	HWW	5
Gauge, Depth	HTJ	5
Ventilator, Non-Continuous (Respirator)	BZD	5
Mask, Oxygen	BYG	5
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	5
Stylet, Tracheal Tube	BSR	5
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	4
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	4
Arthroscope	HRX	4
Reamer	HTO	4
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	4
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	4
Thoracolumbosacral Pedicle Screw System	NKB	4
Device, Fixation, Proximal Femoral, Implant	JDO	4
Shoulder Prosthesis, Reverse Configuration	PHX	4
Orthopedic Stereotaxic Instrument	OLO	4
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	4
Driver, Wire, And Bone Drill, Manual	DZJ	4
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	4
Rasp	HTR	4
Sacroiliac Joint Fixation	OUR	4
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	4
Kit, Surgical Instrument, Disposable	KDD	4
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	4
Stylet, Surgical, General & Plastic Surgery	GAH	4
Bit, Surgical	GFG	4
Container, Liquid Medication, Graduated	KYW	4
Cover, Mattress (Medical Purposes)	FMW	4
Mixer, Cement, For Clinical Use	JDZ	4
Retractor, All Types	EIG	4
Catheter And Tip, Suction	JOL	4
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	PAO	4
Guide, Drill, Ligament	LXI	4
Rasp, Surgical, General & Plastic Surgery	GAC	4
Punch, Surgical	LRY	4
Screwdriver	HXX	4
Washer, Bolt, Nut, Non-Spinal, Metallic	NDG	4
Probe	HXB	4
Orthopaedic Surgical Planning And Instrument Guides	PBF	4
System, Image Processing, Radiological	LLZ	4
Caliper	KTZ	4
Elevator, Surgical, General & Plastic Surgery	GEG	4
Elevator	HTE	4
Extractor	HWB	4
Driver, Prosthesis	HWR	4
Instrument, Cutting, Orthopedic	HTZ	4
Broach	HTQ	4
Cannula, Nasal, Oxygen	CAT	4
Container, Specimen, Sterile	FMH	4
Pad, Menstrual, Unscented	HHD	4
Lens, Spectacle, Non-Custom (Prescription)	HQG	4
Airway, Oropharyngeal, Anesthesiology	CAE	4
Dam, Rubber	EIE	4
Pump, Breast, Powered	HGX	4

Makers in Malaysia

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
WRP Asia Pacific Sdn. Bhd.	SALAK TINGGI, SEPANG Selangor, Malaysia	12	105	0	1	api.fda.gov
Hartalega NGC Sdn. Bhd. (lot 39496)	Sepang Selangor, Malaysia	7	83	0	0	api.fda.gov
Hartalega Sdn Bhd	Bestari Jaya Selangor, Malaysia	5	62	0	0	api.fda.gov
Hartalega NGC Sdn Bhd	Sepang Selangor, Malaysia	7	49	0	0	api.fda.gov
Materialise Sdn Bhd	Petaling Jaya Selangor, Malaysia	18	45	0	0	api.fda.gov
Kossan International Sdn Bhd	Shah Alam Selangor, Malaysia	6	41	0	0	api.fda.gov
Brightway Holdings Sdn. Bhd.	KLANG, Selangor, Malaysia	4	29	0	0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	23	29	0	0	api.fda.gov
Teleflex Medical Sdn. Bhd.	KAMUNTING Perak, Malaysia	17	29	0	0	api.fda.gov
Latexx Manufacturing Sdn. Bhd.	TAIPING Perak, Malaysia	6	23	0	0	api.fda.gov
Cochlear Malaysia Sdn Bhd	Kuala Lumpur, Malaysia	7	19	3	0	api.fda.gov
Yty Industry (manjung) Sdn. Bhd.	SITIAWAN Perak, Malaysia	4	21	0	0	api.fda.gov
GX Corporation Sdn Bhd (Specialty Plant)	Klang Selangor, Malaysia	5	19	0	0	api.fda.gov
Molnlycke Health Care SDN BHD	KULIM Kedah, Malaysia	2	17	0	0	api.fda.gov
Molnlycke Health Care Sdn. Bhd.	Kuala Ketil Kedah, Malaysia	2	17	0	0	api.fda.gov
Ansell Seremban Sdn. Bhd	Seremban Negeri Sembilan, Malaysia	6	16	0	0	api.fda.gov
Karex Industries Sdn Bhd	PONTIAN Johor, Malaysia	5	16	0	0	api.fda.gov
TG Medical Sdn Bhd	KLANG Selangor, Malaysia	7	16	0	0	api.fda.gov
Ansell N.P. Sdn. Bhd.	Melaka, Malaysia	5	15	0	0	api.fda.gov
Central Medicare Sdn Bhd	Teluk Intan Perak, Malaysia	6	15	0	0	api.fda.gov
Eco Medi Glove Sdn Bhd	Taiping Perak, Malaysia	4	15	0	0	api.fda.gov
Abbott Medical	Penang Pulau Pinang, Malaysia	15	5	9	0	api.fda.gov
Boston Scientific Medical Device (Malaysia) SDN BHD	Taman Perindustrian Batu Kawan Pulau Pinang, Malaysia	7	14	0	0	api.fda.gov
GMP Medicare Sdn Bhd(F25)	Klang Selangor, Malaysia	6	13	0	0	api.fda.gov
Supermax Glove Manufacturing Sdn Bhd	SUNGAI BULOH Selangor, Malaysia	3	13	0	0	api.fda.gov
Comfort Rubber Gloves Industries Sdn Bhd	TAIPING Perak, Malaysia	4	12	0	0	api.fda.gov
Masimo Medical Technologies (Malaysia) SDN BHD	Pasir Gudang Johor, Malaysia	23	12	0	0	api.fda.gov
Molnlycke Health Care SDN BHD	Kulim Kedah, Malaysia	1	12	0	0	api.fda.gov
GP Lumut	Sitiawan Perak, Malaysia	4	11	0	0	api.fda.gov
N.S. Uni-Gloves Sdn. Bhd.	SEREMBAN Negeri Sembilan, Malaysia	2	11	0	0	api.fda.gov
I Quality Rubber Industries Sdn. Bhd.	Matang Perak, Malaysia	3	10	0	0	api.fda.gov
JR Engineering And Medical Technologies (M) Sdn Bhd	RASA Selangor, Malaysia	6	10	0	0	api.fda.gov
Riverstone Resources Sdn Bhd	TAIPING Perak, Malaysia	3	10	0	0	api.fda.gov
Ug Global Resources Sdn Bhd	Seremban Negeri Sembilan, Malaysia	2	10	0	0	api.fda.gov
Visco Technology Sdn. Bhd	Prai Pulau Pinang, Malaysia	2	10	0	0	api.fda.gov
HL Rubber Industries Sdn Bhd	KUALA PILAH Negeri Sembilan, Malaysia	3	9	0	0	api.fda.gov
Pleasure Latex Products Sdn. Bhd.	JERAM Selangor, Malaysia	3	9	0	0	api.fda.gov
Tekmedic (M) Sdn Bhd	Melaka, Malaysia	3	9	0	0	api.fda.gov
Maxter Glove Manufacturing Sdn Bhd	KLANG Selangor, Malaysia	4	8	0	0	api.fda.gov
Multisafe Sdn Bhd	BIDOR Perak, Malaysia	2	8	0	0	api.fda.gov
Riverstone Resources Sdn. Bhd.	BUKIT BERUNTUNG, Selangor, Malaysia	5	8	0	0	api.fda.gov
Innolatex Sdn. Bhd	PORT KLANG Selangor, Malaysia	2	7	0	0	api.fda.gov
Kossan Latex Industries (M) Sdn Bhd	KLANG Selangor, Malaysia	5	7	0	0	api.fda.gov
Owen Mumford Sdn Bhd	Iskandar Puteri Johor, Malaysia	5	7	0	0	api.fda.gov
Bergamot Sdn Bhd	KAJANG Selangor, Malaysia	3	6	0	0	api.fda.gov
Careglove Global Sdn Bhd	Seremban Negeri Sembilan, Malaysia	6	6	0	0	api.fda.gov
Koon Seng Sdn Bhd	Tangkak Johor, Malaysia	5	6	0	0	api.fda.gov
Matang MFG. Sdn. Bhd.	MERLIMAU Melaka, Malaysia	3	6	0	0	api.fda.gov
Maxwell Glove Manufacturing Bhd	KAMUNTING Perak, Malaysia	2	6	0	0	api.fda.gov
Mediquip Sdn. Bhd.	Kangar Perlis, Malaysia	3	6	0	0	api.fda.gov
Perusahaan Getah Asas Sdn. Bhd.	JERAM Selangor, Malaysia	5	6	0	0	api.fda.gov
Top Glove Sdn. Bhd.	KLANG Selangor, Malaysia	6	6	0	0	api.fda.gov
Yty Acheh	Sitiawan Perak, Malaysia	4	6	0	0	api.fda.gov
Encompass Industries Sdn. Bhd.	KEMAMAN Terengganu, Malaysia	7	5	0	0	api.fda.gov
AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.)	SUNGAI PETANI Kedah, Malaysia	4	4	0	0	api.fda.gov
Ciba Vision Johor SDN.BHD.	Gelang Patah, Johor Darul Takzim, Malaysia	2	3	1	0	api.fda.gov
Gallant Quality Sdn. Bhd.	Taiping, Perak, Malaysia	4	4	0	0	api.fda.gov
Itl Asia Pacific Sdn Bhd	Batu Gajah Perak, Malaysia	12	4	0	0	api.fda.gov
Mah Sing Healthcare Sdn Bhd	Klang Selangor, Malaysia	4	4	0	0	api.fda.gov
Oon Corp Resources (M) Sdn Bhd	SEREMBAN Negeri Sembilan, Malaysia	1	4	0	0	api.fda.gov
Professional Latex Sdn Bhd	Kamunting Perak, Malaysia	2	4	0	0	api.fda.gov
Wear Safe (malaysia) Sdn Bhd	KLANG Selangor, Malaysia	6	4	0	0	api.fda.gov
Cross Protection M Sdn Bhd	Klang Selangor, Malaysia	4	3	0	0	api.fda.gov
Dexcom (Malaysia) Sdn. Bhd.	Bandar Cassia Pulau Pinang, Malaysia	4	3	0	0	api.fda.gov
KSG Medicare Sdn Bhd	Tangkak Johor, Malaysia	4	3	0	0	api.fda.gov
Meditop Corporation (M) Sdn Bhd	Baru Bangi,Selangor Darul Ehsa, Malaysia	2	3	0	0	api.fda.gov
New Era Medicare Sdn Bhd	Teluk Intan Perak, Malaysia	4	3	0	0	api.fda.gov
Onetexx Sdn Bhd	Kamunting Perak, Malaysia	4	3	0	0	api.fda.gov
Professional Latex Sdn Bhd	Kamunting Perak, Malaysia	5	3	0	0	api.fda.gov
Professional Latex Sdn. Bhd.	KAMUNTING Perak, Malaysia	5	3	0	0	api.fda.gov
The Laryngeal Mask Company (M) SDN. BHD.	Kulim Kedah, Malaysia	4	3	0	0	api.fda.gov
Wear Safe (malaysia) Sdn. Bhd.	KLANG Selangor, Malaysia	6	3	0	0	api.fda.gov
3a Glove Sdn. Bhd.	Senai Johor, Malaysia	3	2	0	0	api.fda.gov
Nitrilist Gloves Manufacturing Sdn Bhd	KUALA PILAH, Negeri Sembilan, Malaysia	1	2	0	0	api.fda.gov
Nulatex Sdn. Bhd.	Kluang Johor, Malaysia	1	2	0	0	api.fda.gov
P Scientific Sdn. Bhd.	Masai Johor, Malaysia	5	2	0	0	api.fda.gov
Pentavest Holdings Sdn Bhd	Batu Melaka, Malaysia	2	2	0	0	api.fda.gov
Qube Medical Products Sdn Bhd	Rawang Selangor, Malaysia	2	2	0	0	api.fda.gov
Shuyou Industrial Malaysia SDN.BHD.	GEORGE TOWN Perak, Malaysia	2	2	0	0	api.fda.gov
Supervision Optimax Sdn Bhd	SUNGAI BULOH Selangor, Malaysia	2	2	0	0	api.fda.gov
SmartSurgN Sdn Bhd	Balakong Selangor, Malaysia	2	2	0	0	api.fda.gov
Tan Sin Lian Industries Sdn. Bhd.	MUAR Johor, Malaysia	1	2	0	0	api.fda.gov
Aamedix Glove Sdn Bhd	Shah Alam Selangor, Malaysia	1	1	0	0	api.fda.gov
BACTIGUARD (South East Asia) Sdn. Bhd.	Penang Science Park Pulau Pinang, Malaysia	1	1	0	0	api.fda.gov
Betelcare Sdn Bhd	Kapar Selangor, Malaysia	1	1	0	0	api.fda.gov
Creative Contract (M) Sdn Bhd	Klang Selangor, Malaysia	1	1	0	0	api.fda.gov
Dispo-Med (malaysia) Sdn Bhd	Shah Alam Selangor, Malaysia	3	1	0	0	api.fda.gov
Dynacare Sdn Bhd	Sitiawan Perak, Malaysia	2	1	0	0	api.fda.gov
Eco Medi Glove Sdn Bhd	Taiping Perak, Malaysia	3	1	0	0	api.fda.gov
Elastomade Accessories Sdn Bhd	Port Klang Selangor, Malaysia	2	1	0	0	api.fda.gov
Eurolatex Sdn Bhd	Kedah, Malaysia	1	1	0	0	api.fda.gov
Fitson Sdn Bhd	Senai Johor, Malaysia	3	1	0	0	api.fda.gov
Glovmaster Sdn. Bhd	BANTING Selangor, Malaysia	1	1	0	0	api.fda.gov
GMP Medicare Sdn Bhd	Siliau Negeri Sembilan, Malaysia	3	1	0	0	api.fda.gov
GN ReSound (Malaysia) Sdn. Bhd	Senai Johor, Malaysia	6	1	0	0	api.fda.gov
Ineo Tech Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	3	1	0	0	api.fda.gov
K-One MediTech Sdn. Bhd	Ipoh Perak, Malaysia	15	1	0	0	api.fda.gov
Kin Yat Industrial (malaysia) Sdn. Bhd.	Senai Johor, Malaysia	1	1	0	0	api.fda.gov
Richter Rubber Technology Sdn. Bhd.	KUALA KETIL Kedah, Malaysia	1	1	0	0	api.fda.gov
Sanctuary Health Sdn Bhd	Chemor Perak, Malaysia	10	1	0	0	api.fda.gov
The Female Health Company (M) Sdn Bhd	Balakong Selangor, Malaysia	1	0	1	0	api.fda.gov
V3bio Sdn. Bhd.	Penang Pulau Pinang, Malaysia	1	1	0	0	api.fda.gov
Vital Healthcare Sdn. Bhd.	Kapar Selangor, Malaysia	1	1	0	0	api.fda.gov
Wear Safe (malaysia) Sdn. Bhd.-Facility Ii	Klang Selangor, Malaysia	4	1	0	0	api.fda.gov
3D Instrumentation Sdn Bhd	Bukit Mertajam Pulau Pinang, Malaysia	20	0	0	0	api.fda.gov
Ambu SDN.BHD.	PENANG Pulau Pinang, Malaysia	15	0	0	0	api.fda.gov
Antmed Malaysia Sdn Bhd	Port Dickson Negeri Sembilan, Malaysia	2	0	0	0	api.fda.gov
Armstrong Electronics Sdn Bhd	Kulai Johor, Malaysia	1	0	0	0	api.fda.gov
Arts Optic Lab (M) Sdn Bhd	TELUK PANGLIMA GARANG Selangor, Malaysia	1	0	0	0	api.fda.gov
Agilent Technologies LDA	Penang Pulau Pinang, Malaysia	3	0	0	0	api.fda.gov
Altek Medical Sdn. Bhd.	Iskandar Puteri Johor, Malaysia	2	0	0	0	api.fda.gov
Avalanche Med Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	9	0	0	0	api.fda.gov
B. Braun Medical Industries Sdn. Bhd.	PENANG Pulau Pinang, Malaysia	82	0	0	0	api.fda.gov
Bard Sdn. Bhd.	KULIM Kedah, Malaysia	9	0	0	0	api.fda.gov
Biocytech Corporation Sdn Bhd	Perak, Malaysia	5	0	0	0	api.fda.gov
Broadland Garment Industries Sdn. Bhd.	Johor Bahru, Malaysia	1	0	0	0	api.fda.gov
Brosmed Medical (malaysia) Sdn. Bhd.	Simpang Ampat Pulau Pinang, Malaysia	3	0	0	0	api.fda.gov
CCB Medical Devices Sdn Bhd	SIMPANG AMPAT Pulau Pinang, Malaysia	3	0	0	0	api.fda.gov
Celestica Electronics (M) Sdn Bhd	Johor Bahru, Malaysia	4	0	0	0	api.fda.gov
CM2	Teluk Intan Perak, Malaysia	2	0	0	0	api.fda.gov
D&K Engineering Services Sdn. Bhd.	Ulu Tiram Johor, Malaysia	1	0	0	0	api.fda.gov
Dlab Scientific Malaysia SDN.BHD	Senai Johor, Malaysia	3	0	0	0	api.fda.gov
Dodo Ventures Sdn. Bhd	Subang Jaya Selangor, Malaysia	1	0	0	0	api.fda.gov
Durio Ppe Sdn. Bhd.	Johor Bahru, Malaysia	2	0	0	0	api.fda.gov
Diptech Industries Sdn.Bhd.	Sungai Petani Kedah, Malaysia	3	0	0	0	api.fda.gov
Eco Medi Glove Sdn Bhd	Taiping Perak, Malaysia	4	0	0	0	api.fda.gov
Emico Penang Sdn Bhd	Bayan Lepas Pulau Pinang, Malaysia	7	0	0	0	api.fda.gov
Epsilon Medical Devices Sdn Bhd.	Kamunting Perak, Malaysia	2	0	0	0	api.fda.gov
Global Tech Plastic Industry Sdn Bhd	ULU TIRAM Johor, Malaysia	1	0	0	0	api.fda.gov
Gmmi Sdn Bhd	IPOH Perak, Malaysia	2	0	0	0	api.fda.gov
GN ReSound (Malaysia) Sdn Bhd.	Kulai Johor, Malaysia	7	0	0	0	api.fda.gov
Goldreign Plastics (M) Sdn Bhd	kajang Selangor, Malaysia	2	0	0	0	api.fda.gov
Greatcare 4u Sdn Bhd	Selangor Darul Ehsan, Malaysia	13	0	0	0	api.fda.gov
Guppy Plastic Industries (penang) Sdn Bhd	Bukit Mertajam, Penang Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
Hamagawa Industrial (M) Sdn Bhd	Sungai Petani Kedah, Malaysia	1	0	0	0	api.fda.gov
Histotech Engineering Sdn. Bhd	Bayan Lepas Pulau Pinang, Malaysia	2	0	0	0	api.fda.gov
Hochuen Medical Sdn. Bhd.	SENAI Johor, Malaysia	19	0	0	0	api.fda.gov
Hosiden Electronics (malaysia) Sendirian Berhad	Bandar Baru Bangi Selangor, Malaysia	1	0	0	0	api.fda.gov
Hospitech Manufacturing Services Sdn Bhd	Shah Alam Selangor, Malaysia	30	0	0	0	api.fda.gov
Haemonetics Malaysia Sdn Bhd	Penang Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.	Kulim Kedah, Malaysia	2	0	0	0	api.fda.gov
Ideal Quality Sdn Bhd	KLANG Selangor, Malaysia	4	0	0	0	api.fda.gov
Ideal Quality Sdn Bhd	Klang Selangor, Malaysia	4	0	0	0	api.fda.gov
Innovate Medical Malaysia, Sdn. Bhd.	Shah Alam Selangor, Malaysia	1	0	0	0	api.fda.gov
Innovatif Cekal Sdn Bhd	Klang Selangor, Malaysia	2	0	0	0	api.fda.gov
Iot Manufacturing Sdn. Bhd.	PASIR GUDANG Johor, Malaysia	2	0	0	0	api.fda.gov
Isd Meditech Sdn. Bhd.	PETALING JAYA Selangor, Malaysia	1	0	0	0	api.fda.gov
Itg Electronics (malaysia) Sdn. Bhd.	Tampoi, Johor Bahru, Malaysia	1	0	0	0	api.fda.gov
Innovex Medical (Malaysia) Sdn.Bhd	Gelang Patah Johor, Malaysia	1	0	0	0	api.fda.gov
Insulet Malaysia Sdn. Bhd.	Iskandar Puteri Johor, Malaysia	1	0	0	0	api.fda.gov
Intersurgical Medical Sdn. Bhd.	Simpang Ampat Pulau Pinang, Malaysia	6	0	0	0	api.fda.gov
Inventec Appliances (Malaysia) Sdn Bhd	Bayan Lepas Pulau Pinang, Malaysia	3	0	0	0	api.fda.gov
J&y Safety (M) Sdn. Bhd.	SHAH ALAM Selangor, Malaysia	6	0	0	0	api.fda.gov
Jayfen Health (malaysia) Sdn. Bhd.	KLANG Selangor, Malaysia	3	0	0	0	api.fda.gov
Jayfen Health (malaysia) Sdn. Bhd.	KLANG Selangor, Malaysia	2	0	0	0	api.fda.gov
Jiann Lih Safety Products (M) Sdn Bhd	Banting Selangor, Malaysia	2	0	0	0	api.fda.gov
Jie Gao Medical Plastic Products (malaysia) Sdn. Bhd.	Klang Selangor, Malaysia	12	0	0	0	api.fda.gov
Jingxin Group (M) Sdn Bhd	Kulai Johor, Malaysia	10	0	0	0	api.fda.gov
Jingxin Group (M) Sdn Bhd	Kulai Johor, Malaysia	10	0	0	0	api.fda.gov
Jso Technology SDN.BHD.	KUALA LANGAT Selangor, Malaysia	1	0	0	0	api.fda.gov
Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
K-One Meditech Sdn. Bhd.	Sekinchan Selangor, Malaysia	2	0	0	0	api.fda.gov
Key Asic Berhad	PETALING JAYA Selangor, Malaysia	1	0	0	0	api.fda.gov
Kl-Kepong Rubber Products Sdn. Bhd.	IPOH Perak, Malaysia	4	0	0	0	api.fda.gov
KLS Martin Malaysia Sdn. Bhd.	Simpang Ampat Pulau Pinang, Malaysia	39	0	0	0	api.fda.gov
Knowles Electronics (malaysia) Sdn. Bhd.	BAYAN LEPAS Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
Kibaru Manufacturing Sdn. Bhd.	Sugai Petani Kedah, Malaysia	1	0	0	0	api.fda.gov
L Well Medtech Solutions Sdn. Bhd.	Nibong Tebal Pulau Pinang, Malaysia	13	0	0	0	api.fda.gov
Labchem Sdn. Bhd	PETALNG JAYA Selangor, Malaysia	8	0	0	0	api.fda.gov
Laglove (M) Sdn. Bhd.	KAJANG, Selangor, Malaysia	1	0	0	0	api.fda.gov
LH Plus Sdn. Bhd.	Shah Alam Selangor, Malaysia	2	0	0	0	api.fda.gov
LKL Advance Metaltech Sdn Bhd	Seri Kembangan Selangor, Malaysia	9	0	0	0	api.fda.gov
Lunarsea Personal Care Supplies SDN. BHD	PUNCAK ALAM Selangor, Malaysia	8	0	0	0	api.fda.gov
Madewell Medical Technology (malaysia) Sdn., Bhd.	Kuala Ketil Kedah, Malaysia	8	0	0	0	api.fda.gov
Maple Tree Medical Devices Sdn Bhd	Johor Bahru, Malaysia	8	0	0	0	api.fda.gov
Mehow Medical (M) Sdn. Bhd.	Simpang Ampat Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
Meiban Technologies (M) Sdn. Bhd	Ulu Tiram Johor, Malaysia	1	0	0	0	api.fda.gov
MedDev Manufacturing Sdn Bhd	Klang Selangor, Malaysia	1	0	0	0	api.fda.gov
Meiban Micro Sdn Bhd	Ulu Tiram Johor, Malaysia	2	0	0	0	api.fda.gov
N.K Rubber (M) Sdn. Bhd.	SKUDAI Johor, Malaysia	1	0	0	0	api.fda.gov
Olylife International Sdn Bhd	Wilayah Persekutuan Kuala Lumpur, Malaysia	2	0	0	0	api.fda.gov
Opulent Solutions SDN.BHD.	Bayan Lepas Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, Malaysia	29	0	0	0	api.fda.gov
Pacewell Asia Sdn. Bhd.	Batu Gajah Perak, Malaysia	3	0	0	0	api.fda.gov
Packerman Sdn. Bhd.	Melaka, Malaysia	1	0	0	0	api.fda.gov
Pintarmas Sdn Bhd	Johor Bahru, Malaysia	1	0	0	0	api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.	IPOH Perak, Malaysia	23	0	0	0	api.fda.gov
Polycore Optical (M) Sdn Bhd	SENAI Johor, Malaysia	1	0	0	0	api.fda.gov
PPC Moulding Services (Malaysia) Sdn Bhd.	Senai Johor, Malaysia	1	0	0	0	api.fda.gov
Protech Paper Sdn Bhd	Nilai Negeri Sembilan, Malaysia	1	0	0	0	api.fda.gov
Pak Mane Brush (Malaysia) Sdn. Bhd.	Pasir Gudang Johor, Malaysia	1	0	0	0	api.fda.gov
Peri-dent Star Sdn. Bhd.	Nilai Negeri Sembilan, Malaysia	1	0	0	0	api.fda.gov
Plexus Manufacturing Sdn. Bhd.	Bayan Lepas Pulau Pinang, Malaysia	30	0	0	0	api.fda.gov
Plexus Manufacturing Sdn.Bhd.	Bayan Lepas Pulau Pinang, Malaysia	16	0	0	0	api.fda.gov
Profound Rubber Ind Sdn Bhd	Seberang Perai Tengah Pulau Pinang, Malaysia	2	0	0	0	api.fda.gov
Quantige Industry Sdn Bhd	Shah Alam Selangor, Malaysia	1	0	0	0	api.fda.gov
Rmo	Johor Bahru, Malaysia	3	0	0	0	api.fda.gov
ResMed Malaysia Operations Sdn Bhd	Senai Johor, Malaysia	5	0	0	0	api.fda.gov
Selia-Tek Medical Sdn Bhd	Petaling Jaya Selangor, Malaysia	3	0	0	0	api.fda.gov
Sina-Sterilgamma Sdn Bhd	Pelabuhan Klang Selangor, Malaysia	9	0	0	0	api.fda.gov
Sinorita Sendirian Berhad	CHERAS Selangor, Malaysia	1	0	0	0	api.fda.gov
SKP BM Electronics Sdn. Bhd.	Senai Johor, Malaysia	2	0	0	0	api.fda.gov
SMP Medtech Sdn. Bhd.	Nilai Negeri Sembilan, Malaysia	2	0	0	0	api.fda.gov
Steripack Asia Sdn Bhd	Klang Selangor, Malaysia	11	0	0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	140	0	0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	140	0	0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	140	0	0	0	api.fda.gov
Sunningdale Tech Penang Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
Supercomal Medical Products, Sdn Bhd	SUNGAI PETANI Kedah, Malaysia	19	0	0	0	api.fda.gov
Sanmina-SCI Systems (Malaysia) Sdn Bhd	Perai Pulau Pinang, Malaysia	5	0	0	0	api.fda.gov
Star Plastics Industrial Co., Sdn Bhd	Nilai Negeri Sembilan, Malaysia	2	0	0	0	api.fda.gov
Symmetry Medical Malaysia Sdn Bhd (758243-M)	Bayan Lepas Pulau Pinang, Malaysia	21	0	0	0	api.fda.gov
Tecan Cdmo Solutions PN Sdn. Bhd.	Penang Pulau Pinang, Malaysia	6	0	0	0	api.fda.gov
Technocom Systems Sdn Bhd	Johor Bahru, Malaysia	3	0	0	0	api.fda.gov
Tele-Paper (M) Sdn Bhd	Shah Alam,Selangor Darul Ehsan, Malaysia	1	0	0	0	api.fda.gov
Terang Nusa (malaysia) Sdn. Bhd.	Kota Bharu Kelantan, Malaysia	4	0	0	2	api.fda.gov
TMT Manufacturing Sdn Bhd	Butterworth Pulau Pinang, Malaysia	1	0	0	0	api.fda.gov
Trolli Master Sdn. Bhd (malaysia)	KUALA LANGAT Selangor, Malaysia	5	0	0	0	api.fda.gov
Texstrip Manufacturing SDN.BHD.	Darul Ehsan Selangor, Malaysia	1	0	0	0	api.fda.gov
The Hygenic Corporation	Batu Gajah Perak, Malaysia	5	0	0	0	api.fda.gov
Toa Tec (M) SDN BHD	Malaysia Johor, Malaysia	1	0	0	0	api.fda.gov
Unip Plastic Industries Sdn Bhd	CHERAS Selangor, Malaysia	11	0	0	0	api.fda.gov
Uro Technology Sdn. Bhd.	PONTIAN Johor, Malaysia	2	0	0	0	api.fda.gov
United Dragons Sdn. Bhd.	Melaka, Malaysia	1	0	0	0	api.fda.gov
Vork Technologies (malaysia) Sdn. Bhd.	Senai Johor, Malaysia	2	0	0	0	api.fda.gov
Watertec (malaysia) Sdn Bhd	Shah Alam Selangor, Malaysia	1	0	0	0	api.fda.gov
Xingchen Arts & Crafts SDN.BHD.	TELOK PANGLI MA Selangor, Malaysia	2	0	0	0	api.fda.gov
Xinmed Sdn. Bhd.	Senai Johor, Malaysia	4	0	0	0	api.fda.gov
Zarapak Sdn. Bhd.	Perak, Malaysia	1	0	0	0	api.fda.gov
Zeito Plastic Components Sdn Bhd	Cheras Selangor, Malaysia	2	0	0	0	api.fda.gov

Updated November 2, 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.