Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

FDA 510(k) Medical Device Manufacturers - India

Indian medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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India FDA 510(k) Overview

Manufacturers

168

Submissions

100%

Clearance rate

Leading India FDA 510(k) manufacturers include Auxein Medical Private Limited, Qure.Ai Technologies, M/s. Meril Endo Surgery Private Limited. and 84 others.

Indian medical device manufacturers have submitted 168 FDA 510(k) notifications since 2018, with a 100% clearance rate across 87 manufacturers. India's growing presence in the FDA 510(k) dataset reflects the country's expanding manufacturing capacity, particularly in disposable devices, diagnostic equipment and in vitro diagnostics.

Active in FDA 510(k) submissions since 2018. Many India manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) India Manufacturers

1–50 of 87

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Auxein Medical Private Limited Sonipat	12	100%	OR	IN
2	Qure.Ai Technologies Mumbai	9	100%	RA	IN
3	M/s. Meril Endo Surgery Private Limited. Chala, Vapi	8	100%	OR SU	IN
4	Allengers Medical Systems Limited Derabassi, Distt Mohali	7	100%	RA	IN
5	Prevest Denpro Limited Bari Brahmana	7	100%	DE	IN
6	Meril Healthcare Pvt. , Ltd. Muktanand Marg, Chala, Vapi	6	100%	OR	IN
7	Poly Medicure Limited Jaipur	6	100%	HO	IN
8	S.H.Pitkar Orthotools Pvt. , Ltd. Pune	5	100%	OR	IN
9	Healthium Medtech Limited Bangalore	5	100%	OR	IN
10	Amazing Rubber Products Pvt, Ltd. Cochin	4	100%	HO	IN
11	Skanray Technologies Limited Mysore	4	100%	RA	IN
12	Prognosys Medical Systems Private Limited Bangalore	3	100%	RA	IN
13	Johari Digital Healthcare Limited Jodhpur	3	100%	PM	IN
14	Ttk Healthcare Limited Puducherry	3	100%	OB	IN
15	Gpc Medical Limited New Delhi	2	100%	OR	IN
16	Sanrea Healthcare Products Pvt, Ltd. Palakkad	2	100%	HO	IN
17	Forus Health Pvt.Ltd Bengaluru	2	100%	OP	IN
18	Global Medikit Limited Dehradun	2	100%	AN HO	IN
19	Indius Medical Technologies Pvt. , Ltd. Pune	2	100%	OR	IN
20	Safey Medical Devices Pvt, Ltd. Pune	2	100%	AN	IN
21	Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. Mahape, Navi Mumbai	2	100%	HO OP	IN
22	Solco Biomedical Company India Private Limited Village-Rajpur	2	100%	OR	IN
23	Lifelong Meditech Private Limited Gurgaon	2	100%	HO	IN
24	Panacea Medical Technologies Pvt. , Ltd. Malur, Kolar District	2	100%	RA	IN
25	Allengers Global Healthcare Private Limited Derabassi, District- Mohali	2	100%	SU	IN
26	Spm Medicare Pvt. , Ltd. Gautam Budh Nagar	2	100%	HO	IN
27	Veol Medical Technologies Pvt , Ltd. Navi Mumbai	2	100%	OB SU	IN
28	Skanray Technologies Pvt, Ltd. Mysore	1	100%	CV	IN
29	Greens Surgicals Pvt. , Ltd. Vadodara	1	100%	OR	IN
30	Beta Healthcare Products Pvt., Ltd. Kochi	1	100%	HO	IN
31	Philips India Limited Pune	1	100%	RA	IN
32	Amzetta Technologies Private Limited Chennai	1	100%	CV	IN
33	Jj Implants Chalakudy	1	100%	DE	IN
34	Lenora Glove Pvt , Ltd. Coimbatore	1	100%	HO	IN
35	Nebula Surgical Private Limited Rajkot	1	100%	OR	IN
36	Biorad Medisys Pvt, Ltd. Pune	1	100%	OR	IN
37	Cupid Limited Nashik	1	100%	OB	IN
38	Auxein Medical Private Limited/71164 Sonipat	1	100%	OR	IN
39	Mediplus (India) Limited Bahadurgarh	1	100%	HO	IN
40	Esstee Exports Health Care Division Tirupur	1	100%	HO	IN
41	Mrk Healthcare Pvt, Ltd. Patan	1	100%	HO	IN
42	Laxmi Dental Exports Pvt, Ltd. Boisar	1	100%	DE	IN
43	Maf Clothing Pvt Ltd Unit-3 Karnataka	1	100%	HO	IN
44	Welspun India Limited District:Kutch	1	100%	HO	IN
45	Allure Gift Wraps Private Limited Vapi	1	100%	HO	IN
46	Niramai Health Analytix Private Limited Bangalore	1	100%	RA	IN
47	Control Print Limited District Solan	1	100%	HO	IN
48	Rivarp Medical Private Limited Bangalore	1	100%	OR	IN
49	Magnum Health and Safety Pvt, Ltd. Taluka - Vasai, Dist - Palghar	1	100%	HO	IN
50	Koove Iot Pvt. , Ltd. Paschim Midnapur	1	100%	HO	IN

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.